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: 

• Tenax Therapeutics (TENX), 7,921% surge in interest
• G1 Therapeutics (GTHX), 1,848% surge in interest
• Tiziana Life Sciences (TLSA), 1,041% surge in interest
• VBI Vaccines (VBIV), 901% surge in interest
• Veracyte (VCYT), 533% surge in interest
• Acadia Pharmaceuticals (ACAD), 328% surge in interest
• Exelixis (EXEL), 288% surge in interest
• Salarius Pharmaceuticals (SLRX), 214% surge in interest
• Sangamo Therapeutics (SGMO), 212% surge in interest
• TG Therapeutics (TGTX), 202% surge in interest

Pipeline and key clinical candidates for these companies:

Tenax Therapeutics is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. Tenax Therapeutics is developing a unique oral formulation of imatinib. The company also owns North American rights to develop and commercialize subcutaneous and oral formulations of levosimendan.

G1 Therapeutics is a commercial-stage biopharmaceutical company whose first commercial product is Cosela, or trilaciclib. G1 is executing a tumor-agnostic development plan evaluating trilaciclib in a variety of solid tumors, including colorectal, breast, lung, and bladder cancers.

Tiziana Life Sciences is a clinical-stage biopharmaceutical company that says its “innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous delivery.” Tiziana’s lead candidate, intranasal foralumab, is the only fully human anti-CD3 mAb, according to the company, which adds that it has “demonstrated a favorable safety profile and clinical response in patients in studies to date.”

VBI Vaccines is a biopharmaceutical company focused on virus-like particles, or VLPs, including a proprietary enveloped VLP, eVLP, platform technology. VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. “VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus, as well as aggressive cancers including glioblastoma,” the company says.

Veracyte is a global diagnostics company whose vision is to transform cancer care for patients all over the world. The company empowers clinicians with the high-value insights they need to guide and assure patients at pivotal moments in the race to diagnose and treat cancer. The Veracyte Diagnostics Platform delivers high-performing cancer tests that are fueled by broad genomic and clinical data, deep bioinformatic and AI capabilities, and a powerful evidence-generation engine, which ultimately drives durable reimbursement and guideline inclusion for our tests, along with new insights to support continued innovation and pipeline development.

Acadia says it is advancing “breakthroughs in neuroscience to elevate life.” The company developed and commercialized what it identifies as “the first and only approved therapies” for hallucinations and delusions associated with Parkinson’s disease psychosis and for the treatment of Rett syndrome. Acadia’s clinical-stage development efforts are focused on treating the negative symptoms of schizophrenia, Alzheimer’s disease psychosis and neuropsychiatric symptoms in central nervous system disorders.

Exelixis is an oncology company that says it is “innovating next-generation medicines and regimens at the forefront of cancer care.” The company says it is rapidly evolving its product portfolio to target an expanding range of tumor types and indications with its clinically differentiated pipeline of small molecules, antibody-drug conjugates and other biotherapeutics.

Salarius Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapies for patients with cancer in need of new treatment options. Salarius’ product portfolio includes seclidemstat, its lead candidate, which is being studied as a potential treatment for pediatric cancers, sarcomas and other cancers with limited treatment options, and SP-3164, an oral small molecule protein degrader being developed for the treatment of non-Hodgkin’s lymphoma. Salarius has received financial support from the National Pediatric Cancer Foundation to advance the Ewing sarcoma program.

Sangamo Therapeutics is a genomic medicine company that says it is “dedicated to translating ground-breaking science into medicines that transform the lives of patients and families afflicted with serious neurological diseases who do not have adequate or any treatment options.” Sangamo’s zinc finger epigenetic regulators are being studied to potentially address neurological disorders and Sangamo’s capsid discovery platform is “making progress toward potentially expanding delivery beyond currently available intrathecal delivery capsids, including in the central nervous system,” Sangamo says.

TG Therapeutics is focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received approval from the FDA for Briumvi, for the treatment of adult patients with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Recent news on these stocks:

August 8

G1 Therapeutics reported Q2 EPS of (10c) against a consensus of (16c), and reported Q2 revenue of $16.5M against a consensus $16.36M. The company believes that its current cash runway is sufficient to fund its operations into Q3 of 2025. “We are excited about what will be possible by the combined Pharmacosmos + G1 team as we meet the needs of more cancer patients. This transaction delivers a significant premium to our shareholders and better and broader access to COSELA for the cancer patients we seek to treat,” said Jack Bailey, CEO. “In the meantime, as we move toward closing, our focus remains on accelerating and expanding the growth of the COSELA business in extensive stage small cell lung cancer; the double-digit quarter-over-quarter growth we experienced in vial volume and net revenue represents continued progress in that regard. We also reaffirmed our 2024 net sales guidance of between $60M-$70M, which is indicative of our continued confidence in the business.” Note that on August 7, G1 announced a definitive merger agreement to be acquired by Pharmacosmos for $7.15 per share.

August 7

Morgan Stanley downgraded Acadia Pharmaceuticals to Equal Weight from Overweight with a price target of $20, down from $28, following the company’s Q2 report. While Nuplazid sales were above expectations, Daybue came in below due to slower than projected new patient starts, the analyst told investors in a research note. The firm said Acadia raised its guidance for Nuplazid but lowered for Daybue. It downgraded the shares looking for confirmation that Acadia’s initiatives translates to greater adoption of its treatment.

Exelixis announced the initiation of the dose-escalation stage of the first-in-human phase 1 clinical trial of XB010 in patients with locally advanced or metastatic solid tumors. XB010, an antibody-drug conjugate consisting of a monomethyl auristatin E payload conjugated to a monoclonal antibody targeting the tumor antigen 5T4, is the first custom ADC generated through Exelixis’ biotherapeutics collaboration network. XB010 was constructed using Catalent’s SMARTag site-specific bioconjugation platform, and its 5T4-targeting mAb was discovered in collaboration with Invenra. Exelixis further announced that the dose-escalation stage of their phase 1, global, open-label study will evaluate XB010 as a single agent and in combination with pembrolizumab to inform the cohort-expansion stage. The expansion cohorts are designed to further assess the tolerability and activity of monotherapy and of the combination in specific indications.

August 6

Tenax Therapeutics has entered into a securities purchase agreement for an oversubscribed private placement financing that is expected to result in total gross proceeds of approximately $100M to the company, before deducting placement agent fees and other private placement expenses. The private placement was led by new investor BVF Partners LP, with participation from other new investors, including Venrock Healthcare Capital Partners, Vivo Capital, Janus Henderson Investors, a large investment management firm, Vestal Point Capital, Velan Capital, ADAR1 Capital Management, LLC, Stonepine Capital Management, and Sphera Biotech. Leerink Partners is acting as the lead placement agent for the private placement and is joined by Guggenheim Securities and William Blair as joint placement agents. ROTH Capital Partners is acting as financial advisor to the company. The company intends to use the net proceeds from the private placement to complete its ongoing Phase 3 LEVEL trial, to initiate all sites and advance enrollment in a second planned Phase 3 trial of oral levosimendan, and for working capital, capital expenditures, and other general corporate purposes. The proceeds from the private placement, combined with the company’s current cash and cash equivalents, are expected to fund the company’s operations through the end of 2027.

Veracyte reported Q2 adjusted EPS 30c against a consensus of (2c), and reported Q2 revenue of $114.4M against a consensus of $100.27M. “Our exceptional second quarter results are a testament to the strength and robustness of Decipher and Afirma,” said Marc Stapley, Veracyte’s CEO. “With both tests clearly gaining share in their respective markets and plenty of headroom for durable future expansion, our confidence in their long-term prospects continues to grow. Meanwhile, our positive cash generation and class-leading profitability profile are fueling a portfolio of tests that are poised to drive meaningful advances in precision medicine.”

Sangamo reported Q2 EPS of (18c) against a consensus of (15c), and reported Q2 revenue of $356,000 against a consensus of $8.26M. Reported cash and cash equivalents as of June 30 of $27.8M, compared to cash, cash equivalents and marketable securities of $81M as of December 31, 2023. The company said, “Sangamo has demonstrated important progress over the last few months, with the announcement of a significant business development agreement with Genentech earlier today; positive topline results from the Phase 3 AFFINE trial in Hemophilia A we are developing with Pfizer; and highly encouraging Phase 1/2 data continuing to accumulate from our wholly-owned Fabry disease program – all of which have the potential to meaningfully extend our cash runway as we continue to advance our wholly owned neurology epigenetic regulation pipeline. Our license agreement with Genentech – the first in what we hope could be multiple capsid collaborations to come with other potential partners – reinforces the potential of our gene editing and STAC-BBB capsid delivery platforms. Our core, and highly focused, neurology pipeline continues to advance as planned and we look forward to providing further updates.”

Sangamo also announced it has entered into a license agreement with Genentech, a member of Roche (RHHBY), to develop intravenously administered genomic medicines to treat certain neurodegenerative diseases. Sangamo has granted Genentech an exclusive license to Sangamo’s proprietary zinc finger repressors that are directed to the tau gene, which is critically involved in Alzheimer’s disease and other tauopathies, as well as an undisclosed second neurology target. Sangamo has also agreed to exclusively license to Genentech, for tau and the second neurology target, Sangamo’s proprietary, neurotropic adeno-associated virus, or AAV, capsid, STAC-BBB, which has demonstrated potent blood-brain barrier penetration and brain transduction in nonhuman primates. Under the terms of the agreement, Sangamo is responsible for completing a technology transfer and certain preclinical activities, and Genentech is responsible for all clinical development, regulatory interactions, manufacturing and global commercialization. Genentech is expected to pay Sangamo $50M in near-term upfront license fees and milestone payments. Sangamo is eligible to earn up to $1.9B in development and commercial milestones spread across multiple potential products under the agreement and tiered royalties on net sales of such products, subject to certain specified reductions. Sangamo continues to engage in business development discussions with additional potential collaboration partners about the Sangamo STAC-BBB capsid delivery platform, its epigenetic regulation capabilities, and other assets, including Fabry disease.

TG Therapeutics reported Q2 EPS 4c against a consensus of (5c), and reported Q2 revenue of $72.596M against a consensus of $65.89M. Michael Weiss, the company’s chairman and CEO stated, “We are pleased to report another quarter of outperformance across all aspects of our business. From a financial standpoint, our second quarter U.S. BRIUMVI net revenues exceeded expectations, leading us to raise our full year guidance. On the R&D side, we also had an exciting quarter with the first patients now treated with subcutaneous ublituximab in a newly launched Phase 1 study and clearance of our IND for azer-cel, our allogeneic “off-the-shelf” CD19 CAR-T, for patients with progressive MS.” Weiss continued, “We are also excited to announce our new $250 million credit facility with HealthCare Royalty and Blue Owl Capital that enables us to accelerate the initiation of a share repurchase program and pay down our current debt, while preserving our current cash to continue building our commercial infrastructure, ramping up our marketing efforts, and investing in our R&D programs. We look forward to continuing the positive momentum into the second half of 2024.”

August 2

VBI Vaccines provided an update on the restructuring proceedings announced on July 30. On August 2, the United States Bankruptcy Court for the District of Delaware granted provisional relief under Chapter 15 of the U.S. Bankruptcy Code, and scheduled a further hearing to consider the recognition of the July 30, 2024, Ontario Superior Court of Justice order, which granted the company protection under the Companies’ Creditors Arrangement Act, R.S.C. 1985, c. C-36, as amended. Additionally, he company received a letter from the listing qualifications department staff of the Nasdaq notifying the company that its common shares will be delisted from Nasdaq effective as of opening of business on August 8. The company does not intend to appeal the delisting determination.

Hear more from InvestingChannel by signing up for The Spill.

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.