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: 

• Harpoon Therapeutics (HARP), 6,359% surge in interest
• Galera Therapeutics (GRTX), 1,645% surge in interest
• Precision BioSciences (DTIL), 1,338% surge in interest
• Seres Therapeutics (MCRB), 1,086% surge in interest
• Cellectar Biosciences (CLRB), 900% surge in interest
• Ardelyx (ARDX), 856% surge in interest
• NovaBay Pharmaceuticals (NBY), 785% surge in interest
• Mersana Therapeutics (MRSN), 750% surge in interest
• Exicure (XCUR), 685% surge in interest
• Cyclacel Pharmaceuticals (CYCC), 669% surge in interest

Pipeline and key clinical candidates for these companies:

Harpoon Therapeutics is developing a novel class of T cell engagers that harness the power of the body’s immune system to treat patients suffering from cancer and other diseases. “Using its proprietary Tri-specific T cell Activating Construct, or TriTAC, platform, Harpoon is developing a pipeline of novel TriTACs initially focused on the treatment of solid tumors and hematologic malignancies. Harpoon has also developed a proprietary ProTriTAC platform, which applies a prodrug concept to its TriTAC platform to create a therapeutic T cell engager that remains inactive until it reaches the tumor. Harpoon’s third proprietary technology platform, extended release TriTAC-XR, is designed to mitigate cytokine release syndrome,” the company states.

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.

Precision BioSciences is an advanced gene editing company dedicated to improving life with its novel and proprietary ARCUS genome editing platform that differs from other technologies in the way it cuts, its smaller size, and its simpler structure. Key capabilities and differentiating characteristics may enable ARCUS nucleases to drive more intended, defined therapeutic outcomes. Using ARCUS, the company’s pipeline is comprised of in vivo gene editing candidates designed to deliver lasting cures for the broadest range of genetic and infectious diseases where no adequate treatments exist.

Seres Therapeutics is a microbiome therapeutics company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Seres’ SER-109 program achieved “the first-ever positive pivotal clinical results for a targeted microbiome drug candidate,” according to the company, and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced to prevent further recurrences of C. difficile infection. Seres is evaluating SER-155 in a Phase 1b study in patients receiving allogeneic hematopoietic stem cell transplantation to reduce incidences of gastrointestinal infections, bloodstream infections and graft-versus-host disease as well as additional preclinical stage programs targeting Infection Protection in medically compromised patients.

Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects. The company’s product pipeline includes lead asset iopofosine, a small-molecule PDC designed to provide targeted delivery of iodine-131, proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.

Ardelyx says it was founded with “a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs.” Ardelyx’s first approved product, Ibsrela is available in the United States and Canada. Ardelyx is developing Xphozah, a novel product candidate to control serum phosphorus in adult patients with chronic kidney disease on dialysis, which has completed three successful Phase 3 trials. Ardelyx has a Phase 2 potassium lowering compound, RDX013, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD.

NovaBay Pharmaceuticals develops and sells eyecare and skincare products. NovaBay’s leading product, Avenova Antimicrobial Lid & Lash Solution, is often prescribed by eyecare professionals for blepharitis and dry-eye disease and is also available directly to eyecare consumers through online distribution channels such as Amazon.

Mersana Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel antibody-drug conjugates and driven by the knowledge that patients are waiting for new treatment options. The company has developed proprietary cytotoxic and immunostimulatory ADC platforms that are generating a pipeline of wholly-owned and partnered product candidates with the potential to treat a range of cancers. Its pipeline includes XMT-1660, a Dolasynthen ADC targeting B7-H4, and XMT-2056, an Immunosynthen ADC targeting a novel epitope of human epidermal growth factor receptor 2, or HER2.

Exicure is an early-stage biotechnology company historically focused on developing nucleic acid therapies targeting ribonucleic acid against validated targets. The company says it continues to actively pursue out-licensing opportunities for its clinical asset, cavrotolimod, as well as for its preclinical candidates, including the SCN9A program for neuropathic pain, and to pursue all strategic alternatives with the goal of maximizing stockholder value.

Cyclacel is a clinical-stage, biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation, epigenetics and mitosis biology. The transcriptional regulation program is evaluating fadraciclib, a CDK2/9 inhibitor, and the epigenetic/anti-mitotic program plogosertib, a PLK1 inhibitor, in patients with both solid tumors and hematological malignancies. Cyclacel’s strategy is to build a diversified biopharmaceutical business based on a pipeline of novel drug candidates addressing oncology and hematology indications.

Recent news on these stocks:

January 9

TG Therapeutics (TGTX) announced that it has entered into an agreement with Precision BioSciences to acquire a worldwide license to Precision’s Azercabtagene Zapreleucel, an allogeneic CD19 CAR T cell therapy program for autoimmune diseases and all other non-oncology indications. Azer-cel is an allogeneic CAR T program and the company has near-term plans to evaluate the program in multiple autoimmune indications, with an investigational new drug filing targeted for mid-2024. Michael Weiss, CEO of TG Therapeutics stated, “We are excited to expand our autoimmune portfolio and leverage our robust drug development and commercialization expertise in partnering with Precision on this CAR T program. We look forward to exploring azer-cel’s potential to be a meaningful therapy for patients with various autoimmune disorders with a target IND filing mid-2024.” Under the terms of the agreement, TG Therapeutics will receive exclusive worldwide rights to develop and commercialize azer-cel in non-oncology indications, and in exchange, Precision will receive upfront and potential near-term economics valued at $17.M. The upfront payment of $7.5M will consist of cash and the purchase of Precision common stock by TG Therapeutics at a 100% premium to the 30-day VWAP prior to purchase. Precision will also receive $2.5M in deferred consideration due within 12 months as an equity investment in Precision’s common stock at a 100% premium to the then 30-day VWAP prior to purchase. Upon the achievement of certain near-term clinical milestones, Precision will receive an additional $7.5M payment, consisting of cash and the purchase of Precision common stock by TG at a 100% premium to the then current 30-day VWAP. Precision is also eligible to receive up to $288M in additional payments based on the achievement of certain clinical, regulatory, and commercial milestones, in addition to high-single-digit to low double-digit royalties on net sales.

NovaBay Pharmaceuticals and Sonoma Pharmaceuticals (SNOA) announced an agreement for the sale and marketing of Avenova-branded products by Sonoma in the European Union. The new products will combine Sonoma’s existing eye product Ocudox, which has already received a Class IIB CE mark for sale in the European Union, with Avenova branding, and are expected to be marketed through Sonoma’s established European distribution network. This agreement brings together NovaBay’s deep knowledge of eye care reflected in its Avenova brand with Sonoma’s expertise in distributing hypochlorous acid products overseas. Sonoma will manufacture Ocudox by Avenova with packaging similar to NovaBay’s Avenova products, which are the leading hypochlorous acid-based eye care products in the U.S. Sonoma will pay NovaBay a royalty fee based on net product sales of Ocudox by Avenova, and Sonoma will continue to market its Ocudox product in the European Union.

January 8

Merck (MRK) and Harpoon Therapeutics announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Harpoon for $23.00 per share in cash for an approximate total equity value of $680M. Under the terms of the agreement, Merck, through a subsidiary, will acquire all outstanding shares of Harpoon Therapeutics for a price per share of $23.00 in cash. The board of directors of Harpoon has unanimously approved the transaction. The transaction is expected to close in the first half of 2024 and will be accounted for as an asset acquisition. Merck expects to record a charge of approximately $650M, or approximately 26c per share, that will be included in non-GAAP results in the quarter that the transaction closes.

Cellectar Biosciences announced data from its CLOVER WaM pivotal study, evaluating iopofosine I 131, a potential first-in-class, targeted radiotherapy candidate for the treatment of relapsed/refractory Waldenstrom’s macroglobulinemia patients that have received at least two prior lines of therapy, including Bruton tyrosine kinase inhibitors. CLOVER WaM is the largest study to date in relapsed or refractory WM patients post-BTKi therapy and represents the most refractory population ever tested in clinical studies based upon a review of published literature. The CLOVER WaM study met its primary endpoint with a major response rate of 61%. The overall response rate in evaluable patients was 75.6%, and 100% of patients experienced disease control. Responses were durable, with median duration of response not reached and 76% of patients remaining progression free at a median follow-up of eight months. These outcomes exceed real world data, which demonstrate a 4-12% MRR and a duration of response of approximately six months or less despite continuous treatment in a patient population that is less pretreated and less refractory to multiple classes of drugs. Notably, iopofosine monotherapy achieved an 8% stringent complete remission in this highly refractory WM population.

Cyclacel Pharmaceuticals announced that it received a notification letter from the Listing Qualifications Department of The Nasdaq Stock Market on January 4, indicating that the company has regained compliance with the minimum bid price requirement set forth in Rule 5550(a)(2) of the Nasdaq Listing Rules.

Ardelyx provided an update on the company’s progress in 2023 and initial expectations for 2024. U.S. net product sales revenue for the first full calendar year of commercialization of IBSRELA is expected to be approximately $80M, subject to adjustment in connection with preparation of audited financial statements, following consistent quarter-over-quarter growth and strong performance across all key indicators, including new and repeat writers and new and refill prescriptions. Ardelyx expects IBSRELA to achieve greater than ten percent market share at peak and generate more than $1.0B in annual U.S. net product sales revenue before patent term expiration. In 2024, the company will continue to invest to support future realization of the full potential for IBSRELA, including the expansion of the IBSRELA sales team, additional promotional programming and omnichannel digital capabilities, increased sampling availability, and expanded support provided by the ArdelyxAssist patient services program. Ardelyx currently expects FY24 U.S. net product sales revenue for IBSRELA to be between $140.0M-$150.0M. Following approval by the FDA of XPHOZAH in October 2023 and launch in November 2023, Ardelyx has seen a strong initial response from the nephrology community. U.S. net product sales revenue for the first quarter of commercialization of XPHOZAH is expected to be approximately $2.5M, subject to adjustment in connection with preparation of audited financial statements. As of December 31, 2023, the company had total cash, cash equivalents and short-term investments of approximately $184M. Ardelyx had approximately 232M shares outstanding as of December 31, 2023.

January 5

Mersana Therapeutics announced business updates, its expected 2024 milestones and its upcoming presentation at the 42nd Annual J.P. Morgan Healthcare Conference. Mersana continues to advance its Phase 1 clinical trial of XMT-1660, the company’s lead Dolasynthen ADC candidate targeting B7-H4. Mersana plans to initiate tumor-specific expansion cohorts in the second quarter of 2024 and share initial dose escalation and backfill cohort data in mid-2024. XMT-2056: Mersana is restarting its Phase 1 clinical trial of XMT-2056, the company’s lead Immunosynthen ADC candidate targeting a novel HER2 epitope. The company plans to advance dose escalation in 2024. In the first half of 2024, Mersana expects to present data at multiple scientific meetings demonstrating Dolasynthen’s differentiation from first-generation cytotoxic ADC platforms. The presentations will include clinical data from two discontinued ADC candidates, XMT-1592 and XMT-1536. Mersana continues to advance its collaborations with Janssen Biotech (JNJ) and Merck KGaA, (MKKGY) Darmstadt, Germany. Financial Resources: Mersana’s cash, cash equivalents and marketable securities as of September 30, 2023 were $241M. The company continues to expect that its available funds will be sufficient to support its current operating plan commitments into 2026.

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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.