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: 

• Deciphera Pharmaceuticals (DCPH), 19,222% surge in interest
• Cyclacel Pharmaceuticals (CYCC), 626% surge in interest
• Geron Corp (GERN), 254% surge in interest
• Daré Bioscience (DARE), 219% surge in interest
• Apellis Pharmaceuticals (APLS), 209% surge in interest
• X4 Pharmaceuticals (XFOR), 204% surge in interest
• Altimmune (ALT), 119% surge in interest
• Mesoblast (MESO), 118% surge in interest
• INmune Bio (INMB), 115% surge in interest

Pipeline and key clinical candidates for these companies:

Deciphera says it is focused on discovering, developing, and commercializing “important new medicines to improve the lives of people with cancer.”  In addition to advancing multiple product candidates from its platform in clinical studies, QINLOCK – Deciphera’s switch-control inhibitor for the treatment of fourth-line GIST – is approved in Australia, Canada, China, the European Union, Hong Kong, Israel, Macau, New Zealand, Singapore, Switzerland, Taiwan, the United Kingdom, and the United States, the company has noted.

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.

Geron is a late-stage biopharmaceutical company pursuing therapies with the potential to extend and enrich the lives of patients living with hematologic malignancies. Its investigational first-in-class telomerase inhibitor, imetelstat, “harnesses Nobel Prize winning science in a treatment that may alter the underlying course of these diseases,” the company says.

Daré Bioscience is advancing products for women’s health, stating that the company’s mission is “to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women’s health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, fertility, and vaginal and sexual health.” Daré’s first FDA-approved product, XACIATO vaginal gel, is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone therapy following menopause.

Apellis Pharmaceuticals says the company “ushered in the first new class of complement medicine in 15 years” with the approval of the first and only targeted C3 therapy. Apellis is advancing this science to “continually develop transformative medicines for people living with rare, retinal, and neurological diseases,” it stated.

X4 Pharmaceuticals is focused on the discovery and development of novel therapies for people with diseases of the immune system. The company’s lead clinical candidate is mavorixafor, a small molecule antagonist of chemokine receptor CXCR4 that is being developed as an oral, once-daily therapy.

Altimmune is a clinical-stage biopharmaceutical company that says it is focused on developing “innovative next-generation therapeutics for the treatment of patients with liver diseases and obesity.” The company’s lead product candidate, pemvidutide, is a GLP-1/glucagon dual receptor agonist that is being developed for the treatment of obesity and NASH. In addition, Altimmune is developing HepTcell, an immunotherapeutic designed to achieve a functional cure for chronic hepatitis B.

Mesoblast refers to itself as “a world leader in developing allogeneic cellular medicines for the treatment of severe and life-threatening inflammatory conditions.” The company states: “Mesoblast has a strong and extensive global intellectual property portfolio with protection extending through to at least 2041 in all major markets… Rexlemestrocel-L is in development for advanced chronic heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblast’s licensees, and the company has established commercial partnerships in Europe and China for certain Phase 3 assets.”

INmune Bio is a clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has two product platforms that are both in clinical trials: The Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. DN-TNF product candidates are being investigated to determine if they can treat cancer (INB03), Early Alzheimer’s disease, and treatment-resistant depression (XPro). The Natural Killer Cell Priming Platform includes INKmune developed to prime a patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic and solid tumor malignancies, and chronic inflammation.

Recent news on these stocks:

April 30

Cyclacel Pharmaceuticals entered into definitive agreements for the purchase and sale of an aggregate of 4.97M shares of common stock, series A warrants to purchase up to 4.97M shares of common stock and short-term series B warrants to purchase up to 4.97M shares of common stock at a purchase price of $1.61 per share of common stock and accompanying warrants in a private placement priced at-the-market under Nasdaq rules. The series A warrants and short-term series B warrants will have an exercise price of $1.36 per share and will be exercisable immediately upon issuance. The series A warrants will expire five and one-half years from the date of issuance and the short-term series B warrants will expire eighteen months from the date of issuance. The private placement is expected to close on or about May 2, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The gross proceeds from the offering are expected to be approximately $8M, prior to deducting placement agent’s fees and other offering expenses payable by the company. The company intends to use the net proceeds from the offering for working capital and other general corporate purposes.

Baird downgraded Geron to Neutral from Outperform with an unchanged price target of $4.50. After the stock’s recent run-up, the firm sees Geron’s risk/reward as balanced. The analyst continues to believe that imetelstat has nearly a 100% probability of approval into the June 16 FDA action date. However, this is now already priced into the stock, the analyst tells investors in a research note. Baird thinks Geron is unlikely to trade much higher from here over the coming months unless the company is acquired, and it is “unable to get high conviction in this happening.”

XOMA (XOMA) has acquired an economic interest in three women’s health assets – XACIATO vaginal gel 2%, Ovaprene and Sildenafil Cream, 3.6% – from Dare Bioscience, for an upfront payment of $22M. XACIATO is approved by the FDA for the treatment of bacterial vaginosis in females 12 years of age and older. In 2022, Dare entered into a license agreement with Organon, which initiated XACIATO commercial marketing activities in the fourth quarter of 2023. Under the terms of the agreement, XOMA will receive the remaining royalties related to XACIATO not already included in Dare’s December 2023 royalty-backed financing agreement, which equates to low to high single-digit royalties on net sales. XOMA also is entitled to potential milestone payments based on the commercial success of XACIATO. Additionally, XOMA has acquired an interest in a potential milestone and a low single-digit synthetic royalty on Ovaprene, as well as a low single-digit synthetic royalty on Sildenafil Cream, 3.6%. Upon achieving a pre-specified return threshold, XOMA will make upside-sharing milestone payments to Dare.

Jefferies noted that Apellis shares are down due to comments on the FDA having released updated FAERS data as of March 31, but the firm’s view on retinal vasculitis cases remains unchanged, as it had noted last week after its database update. The firm, which notes the two deaths in the FAERS data were not related to Syfovre and said regarding RV cases that only four of them actually occurred in Q1, also advises that investors “keep in mind cases reported by the FDA are not adjudicated.” Jefferies has a Buy rating and $80 price target on Apellis.

INmune Bio shares an update on two patients from the Phase 1b trial completed in 2021 who have continued to receive XPro for treatment of Alzheimer’s Disease, AD, for more than three years under the Australian compassionate use program known as the Special Access Scheme, SAS. Both patients, herein referred to as “Patient 1” and “Patient 2,” was an original study participant in the Phase 1b clinical trial, in the target dose 1mg/kg cohort, which commenced in November of 2019 and completed in September of 2021. Reports from the primary care physicians indicate that XPro has been well-tolerated throughout the treatment period, with stable cognitive function observed in the patients. Furthermore, the patients express a desire to continue receiving XPro for Alzheimer’s disease treatment. “We are delighted to report that according to primary care physicians treating these patients under the SAS, the long-term administration of XPro has been safe and well-tolerated with these patients maintaining stable cognitive functions for more than three years of continued XPro treatment,” expressed R.J. Tesi, M.D., CEO of INmune Bio. “Given the typical progression of Alzheimer’s Disease and comparative data from other drug trials, stable cognitive and physical function over this long period is encouraging.”

April 29

Deciphera announced that it has entered into a definitive merger agreement with ONO Pharmaceutical, under which ONO will acquire all outstanding shares of Deciphera common stock for $25.60 per share in cash through a tender offer followed by a merger of Deciphera with a wholly-owned subsidiary of ONO, for a total equity value of $2.4B. The boards of directors of both companies have unanimously approved the transaction. Together, ONO and Deciphera will accelerate their shared vision to deliver innovative new drugs and serve patients around the world. Deciphera brings specialized research and development capabilities in kinase drug discovery, well-established commercial and sales platforms in the United States and Europe, and global clinical development capabilities. In addition to Qinlock – Deciphera’s switch-control inhibitor for the treatment of fourth-line gastrointestinal stromal tumor, or GIST, which is approved in the United States and over 40 other countries, Deciphera also brings a potential medicines, including vimseltinib, DCC-3116 and multiple additional oncology candidates. The acquisition is structured as a tender offer and subsequent merger of Deciphera with a wholly-owned subsidiary of ONO. Under the terms of the definitive merger agreement, ONO will acquire all outstanding shares of Deciphera for $25.60 per share in cash for a total equity value of approximately $2.4B. The purchase price represents a premium of 74.7% to Deciphera’s closing share price of $14.65 on April 26 and a premium of 68.8% to Deciphera’s 30-trading-day volume weighted average price as of April 26. ONO will promptly commence the tender offer, and it will expire 20 business days after its commencement, unless otherwise extended. If the tender offer conditions are not satisfied, ONO may be required to extend the tender offer under certain circumstances. Upon the successful completion of the tender offer, ONO’s wholly-owned subsidiary will merge with and into Deciphera, with Deciphera continuing as the surviving corporation and a wholly-owned subsidiary of ONO, and any shares of common stock of Deciphera not tendered into the offer will receive the same USD per share price payable in the tender offer. The acquisition is expected to close in the third quarter of 2024, subject to customary closing conditions, including U.S. antitrust clearance and the tender of a majority of Deciphera’s outstanding shares of common stock. In connection with the execution of the merger agreement, certain stockholders of the company owning approximately 28% of the outstanding shares of Deciphera Common Stock have entered into tender and support agreements pursuant to which they will tender all of their owned shares in the offer. Upon completion of the acquisition, Deciphera will operate as a standalone business of ONO Group, from its headquarters in Waltham, Massachusetts. In light of the acquisition, Deciphera will not host a first quarter 2024 earnings call.

X4 Pharmaceuticals announced that the FDA has approved XOLREMDI capsules for use in patients 12 years of age and older with WHIM syndrome to increase the number of circulating mature neutrophils and lymphocytes.

Guggenheim downgraded Altimmune to Neutral from Buy with no price target. The lack of a partner emerging five months from the end of Phase 2 “presents an overhang that can no longer be ignored,” contends the analyst, who argues that a partnership for lead asset pemvidutide looks “increasingly unlikely” and that the opportunity to successfully fund pemvidutide’s future in either obesity or fatty liver disease is “growing increasingly tenuous.”

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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.