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: 

• vTv Therapeutics (VTVT), 7,210% surge in interest
• Adial Pharmaceuticals (ADIL), 3,018% surge in interest
• Oragenics (OGEN), 2,387% surge in interest
• CytomX Therapeutics (CTMX), 1,307% surge in interest
• Viking Therapeutics (VKTX), 1,236% surge in interest
• Crinetics Pharmaceuticals (CRNX), 752% surge in interest
• Ligand Pharmaceuticals (LGND), 555% surge in interest
• Denali Therapeutics (DNLI), 527% surge in interest
• Galera Therapeutics (GRTX), 517% surge in interest
• Codexis (CDXS), 451% surge in interest

Pipeline and key clinical candidates for these companies:

vTv Therapeutics is focused on developing oral, small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes. vTv’s development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease, renal disease, primary mitochondrial myopathy, and pancreatic cancer.

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions. The company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder, or AUD, in heavy drinking patients and was recently investigated in the company’s ONWARD pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes identified using the company’s proprietary companion diagnostic genetic test. The company is also developing adenosine analogs for the treatment of pain and other disorders.

Oragenics is a development-stage company focused on nasal delivery of pharmaceutical medications including in neurology and fighting infectious diseases including coronaviruses and multidrug-resistant organisms. It’s ONP-002 product candidate is a fully synthetic neurosteroid being developed to treat Mild Traumatic Brain Injury. Its NT-CoV2-1 product candidate is an intranasal vaccine candidate to prevent COVID-19 and variants of the SARS-CoV-2 virus. The NT-CoV2-1 program leverages coronavirus spike protein research licensed from the National Institutes of Health and the National Research Council of Canada with a focus on reducing viral transmission and offering a more patient-friendly intranasal administration.

CytomX is a clinical-stage, oncology-focused biopharmaceutical company whose pipeline comprises seven therapeutic candidates across multiple treatment modalities including antibody-drug conjugates, or “ADCs,” T-cell engaging bispecific antibodies, or “TCBs,” and immune modulators such as cytokines and checkpoint inhibitors. CX-2029 is an investigational conditionally activated antibody-drug conjugate directed toward CD71, which has demonstrated encouraging antitumor activity in patients with squamous non-small cell lung cancer and is being developed in collaboration with AbbVie (ABBV). CytomX’s clinical pipeline also includes cancer immunotherapeutic candidates against validated targets such as the CTLA-4-targeting Probody therapeutics, BMS-986249 and BMS-986288, partnered with Bristol Myers Squibb (BMY), as well as CX-904, a conditionally activated T-cell-engaging bispecific antibody targeting the epidermal growth factor receptor on tumor cells and the CD3 receptor on T cells, which is partnered with Amgen (AMGN).

Viking Therapeutics is focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders. The company’s clinical programs include VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders, which is currently being evaluated in a Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis, or NASH, and fibrosis.

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.

Ligand Pharmaceuticals is focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Ligand’s Captisol platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand’s Pelican Expression Technology is a “validated and scalable” platform for recombinant protein production that is suited for complex, large-scale protein production “where traditional systems are not,” the company states.

Denali Therapeutics is a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier for the treatment of neurodegenerative diseases and lysosomal storage diseases. Denali pursues new treatments by rigorously assessing genetically validated targets, engineering delivery across the BBB, and guiding development through biomarkers that demonstrate target and pathway engagement.

Galera Therapeutics is focused on developing and commercializing a pipeline of therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera’s selective dismutase mimetic product candidate avasopasem manganese, avasopasem, or GC4419, is being evaluated for radiotherapy-induced toxicities. The company’s second product candidate, rucosopasem manganese, rucosopasem, or GC4711, is in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer.

Codexis is an enzyme engineering company leveraging its proprietary CodeEvolver technology platform to discover, develop and enhance novel, high-performance enzymes and other classes of proteins. “Codexis enzymes solve for real-world challenges associated with small molecule pharmaceuticals manufacturing, nucleic acid synthesis and genomic sequencing, and – as biotherapeutic candidates – they have the potential to treat challenging diseases,” the company says.

Recent news on these stocks:

February 28

vTv Therapeutics has closed a private placement to healthcare-focused institutional investors including a life sciences-focused institutional investor, Samsara BioCapital, and the JDRF T1D Fund, of 464K shares of common stock at a price of $11.81 per share. Total gross proceeds of the PIPE were $51M. Further, in conjunction with the PIPE, vTv has reduced the size of its board from nine to seven members, three of whose members will be designated by the new investors, and includes Srinivas Akkaraju, MD, PhD, Founder and Managing General Partner at Samsara. Additional information regarding the composition of the Board is available in a Current Report on Form 8-K filed with the SEC. vTv expects to use the proceeds from the PIPE to fund the first Phase 3 study of its lead product candidate, cadisegliatin, which is expected to initiate in mid-2024.

Adial Pharmaceuticals announced patent number 11,905,562 was issued on February 20 by the United States Patent and Trademark Office. The patent covers the company’s lead investigational new drug product, AD04, and its ability to target the serotonin transporter gene for the potential treatment of opioid use disorder.

A Viking Therapeutics 6.47M share secondary stock offering priced at $85.00. The deal size was increased to $550M from $350M and it priced below the last closing price of $94.50. Morgan Stanley, Leerink, William Blair, Raymond James, Stifel and Truist acted as joint book running managers for the offering. Viking previously said it intended to use the net proceeds from the offering for continued development of its VK2809, VK2735 and VK0214 programs and for general research and development, working capital and general corporate purposes.

Crinetics reported Q4 EPS of (90c) against a consensus of (86c). Unrestricted cash, cash equivalents, and investments totaled $558.6M as of December 31, 2023, compared to $334.4M as of December 31, 2022. “As we reflect on our achievements in 2023, this was a truly significant year for Crinetics, laying the foundation for our next phase of growth,” said Scott Struthers, CEO of Crinetics. “Our lead investigational compound, paltusotine, continues to demonstrate highly promising results, underscored by the success of the Phase 3 PATHFNDR-1 study in acromegaly and encouraging initial findings in the ongoing Phase 2 study in carcinoid syndrome. Pending results from our second Phase 3 PATHFNDR-2 study this quarter, we are on track to submit a New Drug Application for paltusotine in acromegaly in the second half of 2024. We also expect full results from our Phase 2 study in carcinoid syndrome in the first half of this year. Looking ahead, 2024 and 2025 are poised to be transformational years as we advance our late-stage product candidate and prepare for a potential commercial launch, while also leveraging our world class in-house R&D expertise to enrich our pipeline with additional promising candidates in high-prevalence endocrine and metabolic indications. To support these growth activities, we announced a $350M private placement that is expected to extend our cash runway into 2028.”

February 27

An Oragenics 1.4M share spot secondary stock offering priced at $1.50. The deal priced below the last closing price of $2.45. ThinkEquity and Laidlaw acted as joint book running managers for the offering. The company previously said it intended to use the net proceeds from the offering to fund the continued development of ONP-002, which is a unique neurosteroid drug compound intended to treat mild traumatic brain injuries also known as concussions, and for general corporate purposes and working capital.

Ligand reported Q4 EPS $1.38 against a consensus of 66c, and reported Q4 revenue of $28.10M against a consensus of $25.72M. “2023 was a transformative year for Ligand, both operationally and financially. We refocused the company to be a lean-infrastructure, high-margin business,” said Todd Davis, CEO of Ligand. “We enhanced our deal making capabilities with the strengthening of our senior team and opening of a Boston office. These initiatives will help us execute on a larger scale and continue to expand our portfolio through a focus on life science royalty opportunities. We are now well positioned and resourced to close on multiple new investments. We also saw important clinical and regulatory events across our existing partnered assets and expect this momentum will continue in 2024 and beyond.”

Denali Therapeutics reported Q4 EPS (86c) against a consensus of (80c), and reported Q4 revenue $0 against a consensus of $8.36M. “2023 was a year of significant progress across our broad therapeutic portfolio and further clinical validation of our BBB-crossing Transport Vehicle platform,” said Ryan Watts, Ph.D., CEO of Denali. “In 2024, we expect to complete enrollment of our late-stage trials in MPS II and ALS as we establish commercial readiness for our product candidates in our first peak of programs. In addition, we are well positioned to expand our TV-enabled portfolio to address large neurodegenerative diseases with TV-enabled enzymes, antibodies, and oligonucleotides. We recognize the urgent needs of patients and families living with neurodegenerative and lysosomal storage diseases and we will continue to push for the fastest path to approval of effective medicines.” The company reported that cash, cash equivalents, and marketable securities were approximately $1.03B as of December 31, 2023. For FY24, Denali anticipates its operating expenses will be less than or equal to those in 2023 based on prioritization of its portfolio. With the anticipated proceeds from the PIPE financing, Denali expects the company’s cash runway to extend into 2028.

February 26

Codexis announced it has entered into an agreement with Roche (RHHBY) for an exclusive, global license for the company’s newly engineered double-stranded DNA or dsDNA, ligase for next-generation sequencing library preparation and the Company’s EvoT4 DNA ligase. Under the terms of the deal, Codexis will receive upfront and technical milestone payments. This deal supersedes the prior exclusive license on the EvoT4 DNA ligase. “This transaction is the latest example of our ongoing commitment to focusing on the core areas of our business where we have the biggest opportunity to create impact in the market,” said Kevin Norrett, MBA, COO of Codexis. “Since announcing our prioritized strategy last July, we’ve executed multiple deals to monetize our non-core assets with market-leading companies. We are excited to collaborate again with Roche on this novel, dsDNA ligase. As a leader in NGS technologies, Roche (RHHBY) continues to bring important kits to market that provide the sensitivity and specificity required for the next wave of innovative NGS applications. With Roche’s technical ability and commercial reach, we now have the ability to maximize the potential of our dsDNA ligase.”

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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.