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:

• Genprex (GNPX), 1,669% surge in interest
• Verrica Pharmaceuticals (VRCA), 1,590% surge in interest
• Syros Pharmaceuticals (SYRS), 868% surge in interest
• AnaptysBio (ANAB), 528% surge in interest
• Orgenesis (ORGS), 500% surge in interest
• Siga Technologies (SIGA), 419% surge in interest
• OrganiGram (OGI), 348% surge in interest
• CorMedix (CRMD), 289% surge in interest
• Precigen (PGEN), 244% surge in interest

Pipeline and key clinical candidates for these companies:

Genprex is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options, the company says.

Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. On July 21, 2023, Verrica’s lead product, Ycanth, became the first treatment approved by the FDA to treat pediatric and adult patients with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. VP-102 is also in development to treat common warts and external genital warts, two of the largest unmet needs in medical dermatology. Verrica is developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. Verrica has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize VP-315 for dermatologic oncology conditions.

Syros is committed to developing new standards of care for the frontline treatment of patients with hematologic malignancies. Driven by the motivation to help patients with blood disorders that have largely eluded other targeted approaches, Syros is developing tamibarotene, an oral selective RARalpha agonist in frontline patients with higher-risk myelodysplastic syndrome and acute myeloid leukemia with RARA gene overexpression.

Anaptys is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics. It is developing immune cell modulators for autoimmune and inflammatory diseases, including two checkpoint agonists: ANB032, its BTLA agonist, in a Phase 2b trial for the treatment of atopic dermatitis and rosnilimab, its PD-1 agonist, in a Phase 2b trial for the treatment of rheumatoid arthritis and in a Phase 2 trial for the treatment of ulcerative colitis. It also has other immune cell modulator candidates in its portfolio, including ANB033, an anti-CD122 antagonist antibody, entering a Phase 1 trial and ANB101, a BDCA2 modulator antibody, in preclinical development. In addition, Anaptys has developed two cytokine antagonists available for out-licensing: imsidolimab, an anti-IL-36R antagonist, that has completed Phase 3 trials for the treatment of generalized pustular psoriasis, and etokimab, an anti-IL-33 antagonist that is Phase 2/3 ready. Anaptys has also discovered multiple therapeutic antibodies licensed to GSK in a financial collaboration for immuno-oncology, including an anti-PD-1 antagonist antibody and an anti-TIM-3 antagonist antibody.

Orgenesis is a global biotech company that has been committed to unlocking the potential of cell and gene therapies since 2012 as well as a paradigm-shifting decentralized approach to processing since 2020. This new model allows Orgenesis to bring academia, hospitals, and industry together to make these essential therapies a reality sooner rather than later. Orgenesis is focusing on advancing its CGTs toward eventual commercialization, while partnering with key industry stakeholders to provide a rapid, globally harmonized pathway for these therapies to reach and treat a larger number of patients more cost effectively and with better outcomes through great science and decentralized production.

SIGA Technologies is a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks, vaccines and therapies for emerging infectious diseases, and health preparedness. The company’s lead product is TPOXX, also known as tecovirimat and ST-246, an orally administered and IV formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox in 2018, and the IV formulation was approved for the same indication in 2022.

Organigram is focused on producing high-quality, indoor-grown cannabis for patients and adult recreational consumers in Canada, as well as developing international business partnerships to extend the company’s global footprint. Organigram has also developed a portfolio of legal adult-use recreational cannabis brands, including Edison, Holy Mountain, Big Bag O’ Buds, SHRED, Monjour and Trailblazer.

CorMedix is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The company is focused on developing its lead product DefenCath, a novel, non-antibiotic antimicrobial solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis.

Precigen’s AdenoVerse immunotherapy platform utilizes a library of proprietary adenovectors for the efficient gene delivery of therapeutic effectors, immunomodulators, and vaccine antigens designed to modulate the immune system. Precigen’s gorilla adenovectors, part of the AdenoVerse library, “have potentially superior performance characteristics as compared to current competition. AdenoVerse immunotherapies have been shown to generate high-level and durable antigen-specific T-cell immune responses as well as an ability to boost these responses via repeat administration,” the company says.

Recent news on these stocks:

August 15

Truist raised the firm’s price target on AnaptysBio to $30 from $20 but kept a Hold rating on the shares. The firm is adjusting its model, stating the company deserves some credit for two pipeline programs about to read out Phase 2b data – one for atopic dermatitis in December and another for rheumatoid arthritis in Q1 of 2025, the analyst tells investors in a research note. Truis adds however that there is a fair amount of positive update already priced-in at this juncture.

The National Institutes of Health’s, NIH, National Institute of Allergy and Infectious Diseases, NIAID, announced topline results from a preliminary analysis of the PALM 007 clinical trial. NIAID reported that the study did not meet its primary endpoint of a statistically significant improvement in time to lesion resolution within 28 days post-randomization for patients in the Democratic Republic of the Congo with monkeypox, who were administered SIGA’s tecovirimat, a highly targeted antiviral treatment, versus placebo. All patients in this study were hospitalized for the entire duration of treatment. This study was not a registration study conducted under an FDA Investigational New Drug Application.A meaningful improvement was observed in patients receiving tecovirimat whose symptoms began seven days or fewer before randomization and in those with severe or greater disease, defined by the World Health Organization (WHO) as having 100 or more skin lesions. While more analysis is required, the Company believes these data support further trials to assess the potential benefit of tecovirimat in those who present to medical care soon after symptoms and in those with severe disease.

August 14

Genprex announced positive clinical study updates for its Acclaim-1 and Acclaim-3 clinical trials for the treatment of non-small cell lung cancer, or NSCLC, and small cell lung cancer, or SCLC, respectively, and plans to re-focus its oncology clinical development program. Patients in the company’s lung cancer clinical trials are being treated with the Company’s lead drug candidate, Reqorsa, or quaratusugene ozeplasmid, Gene Therapy. Two patients in the Acclaim-1 study have had prolonged Progression Free Survival, or PFS, and importantly, the first treated patient in the Acclaim-3 study attained a Partial Remission, or PR, from the start of maintenance therapy. Ryan Confer, President and CEO, commented on the update: “We are excited by these early and promising patient responses to REQORSA treatment, particularly as these patients represent some of the most difficult to treat lung cancer patient populations. There is significant unmet medical need for patients afflicted with lung cancer, as nearly all patients’ disease progresses following treatment, even when treated with today’s most advanced targeted therapies and immunotherapies. This leaves patients with limited therapeutic options. We are thrilled our novel gene therapy treatment for lung cancer, REQORSA, is demonstrating early evidence of efficacy with a favorable safety profile. We look forward to continuing to evaluate REQORSA in our lung cancer clinical trials while we advance our efforts to bring new therapies to those battling cancer.” The Acclaim-1 clinical trial is evaluating the combination of REQORSA and AstraZeneca’s (AZN) Tagrisso to treat patients with late-stage NSCLC who have activating EGFR mutations and disease progression after treatment with Tagrisso. The Acclaim-3 clinical trial is evaluating the combination of REQORSA and Genentech’s Tecentriq as a maintenance therapy to treat patients with extensive stage small cell lung cancer who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Confer and the executive team have evaluated resource allocations to ensure streamlined, focused strategies to support expeditious regulatory submissions for REQORSA and will implement the following changes to the Company’s oncology clinical development plans in order to prioritize resources and focus on the most promising aspects of the Acclaim-1 and Acclaim-3 lung cancer clinical trials.

Verrica Pharmaceuticals announced preliminary positive results from Part 2 of its Phase 2 clinical trial studying VP-315, a potential first-in-class oncolytic peptide, for the treatment of basal cell carcinoma. Part 2 preliminary results are based on 93 confirmed basal cell carcinoma lesions that were treated during Part 2 of the Phase 2 trial; however, for histologic reduction in tumor size and overall reduction in tumor size, data from three of the 93 lesions are pending. The key preliminary Part 2 results were: No dose-limiting toxicities or Treatment-Related Serious Adverse Events were reported. Most Treatment Related Adverse Events were expected mild to moderate cutaneous reactions. 51% of lesions treated resulted in complete histologic clearance, with no residual tumor cells. Histological reduction of tumor size in those subjects with remaining tumor was 71%. All patients treated with VP-315 had a reduction in tumor size with an overall reduction of tumor size in all subjects of 86%.

AnaptysBio announced the pricing of an underwritten offering of 2.75M shares of its common stock at a price of $36.50 per share, representing a premium of approximately 10% to Anaptys’ closing price on Aug. 13. The gross proceeds from this offering are expected to be approximately $100M, before deducting underwriting discounts, commissions and other offering expenses payable by Anaptys. All of the shares of common stock are being offered by Anaptys. The offering is expected to close on or about Aug. 15, subject to the satisfaction of customary closing conditions. Sanofi did not receive rights to any of Anaptys’ programs as a part of their equity investment.

Orgenesis announced a strategic partnership agreement with Harley Street Healthcare Group. This partnership aims to accelerate the clinical development and commercialization of advanced wellness and longevity therapies and products to a global customer base, aimed at significantly reducing the impact of lifestyle-related illnesses on people’s health. Under the terms of the agreement, Orgenesis and HSHG will establish a joint venture, with Orgenesis owning 49% and HSHG owning 51% of the entity. The JV will focus on launching innovative health and wellness services, including personalized preventative care and regenerative therapies. The goal is to establish a comprehensive “Health-Wellness-as-a-Service” model, leveraging HSHG’s established healthcare network and Orgenesis’ cutting-edge biotech innovations. The JV intends to introduce a suite of wellness and longevity products by the end of 2024 that will include immune cell banking, aging and longevity therapies, preventative illness screening, and regenerative therapies using stem cells. The initial rollout will target key global regions, including the United Kingdom, UAE, MENA, Canada, ASEAN, the Balkans, Africa, Latam, and the Indian subcontinent. In connection with the agreement, HSHG has agreed to invest up to $10 million over three years into Orgenesis and the joint venture.

CorMedix reported Q2 EPS (25c) against a consensus of (25c), and reported Q2 revenue of $806,119 against a consensus of $1.67M. Joe Todisco, CorMedix CEO, commented, “I am excited about the Company’s recent progress as we have now launched DefenCath in both the inpatient and outpatient settings. I’m very pleased with the early revenue trajectory from our outpatient launch, as well as the progress we are making on the inpatient P&T formulary process. We have also set the stage for expanded indications for the DefenCath technology, which we believe can have a meaningful impact on bloodstream infection rates in new patient populations beyond adult hemodialysis.”

Precigen reported Q2 EPS of (23c) against a consensus of (10c), reported Q2 revenue of $717K against a consensus of $1.28M. “We are all in on PRGN-2012 given the immense unmet need for RRP patients and our groundbreaking pivotal data supporting the potential of what we hope to be the first-ever FDA approved therapy to treat RRP,” said CEO Helen Sabzevari. “By strategically focusing our portfolio, streamlining resources and recent public offering, we have optimized the company to rapidly prepare for submission of a rolling biologics license application under an accelerated approval pathway. We are excited to have initiated enrollment in the confirmatory clinical trial and will continue to accelerate our commercial readiness campaign for a potential launch in 2025 under the leadership of our newly hired Chief Commercial Officer. Additionally, we plan to maximize portfolio value by focusing on strategic partnerships to further advance our highly promising UltraCAR-T programs.” “Our recent reprioritization and public offering is expected to fund our operations into early 2025 allowing us to focus on advancement of PRGN-2012 while continuing to explore potential non-dilutive financing opportunities for future liquidity,” said Harry Thomasian Jr., CFO.

August 13

Organigram reported Q3 revenue of C$41.1M vs. C$32.8M last year, and reported Q3 adjusted EBITDA C$3.5M vs. (C$2.9M) last year. “We are pleased to report a strong third quarter, highlighted by a 25% year-over-year increase in net revenue, and a significant improvement in adjusted EBITDA”, said CEO Beena Goldenberg. “Our strategic investments and partnerships, both domestically and internationally, have positioned us for growth and diversification, particularly in the European market with our investment in Sanity Group. Furthermore, the preliminary results from our landmark PK study on our latest patent pending nanoemulsion technology demonstrate our ongoing commitment to innovation and expanding our product offerings. I continue to be very proud of our dedicated team for their hard work and contributions to these achievements.” CFO Greg Guyatt commented, “We are pleased with the results of our focus on operating efficiencies and resulting margin improvements and positive adjusted EBITDA in the quarter. With $173M in pro-forma cash, we believe we have one of the strongest balance sheets in the industry and are well positioned to capitalize on future growth opportunities.”

August 12

Syros Pharmaceuticals announced that it will discontinue enrollment in the SELECT-AML-1 Phase 2 clinical trial evaluating the triplet regimen of tamibarotene in combination with venetoclax and azacitidine compared to the doublet regimen of venetoclax and azacitidine in newly diagnosed, unfit patients with acute myeloid leukemia and RARA gene overexpression. This decision is based on the results of a prespecified interim analysis of the trial. Data from 51 patients enrolled in SELECT-AML-1 were reviewed on August 9, 2024. This review included a prespecified non-binding futility analysis conducted on the first 40 randomized patients after the fortieth randomized patient received approximately three months of study drug or discontinued treatment. A similar complete response/complete response with incomplete hematologic recovery rate was observed in the triplet arm and the doublet arm. As a result, the probability for success of the SELECT-AML-1 study to demonstrate superiority at the final analysis in 80 randomized patients was considered low, and Syros made the decision to discontinue further enrollment. There were no new safety signals associated with the use of tamibarotene in combination with venetoclax and azacitidine. Patients currently enrolled in SELECT-AML-1 will have the opportunity to remain on study at the discretion of study investigators. Syros plans to present data from SELECT-AML-1 at the 12th Annual Meeting of the Society of Hematologic Oncology in September 2024. “We are disappointed by this unexpected outcome, especially for people living with AML,” said David A. Roth, M.D., Chief Medical Officer of Syros. “In our prior Phase 2 clinical trial, the doublet combination of tamibarotene and azacitidine delivered a 61% CR/CRi rate in newly diagnosed AML patients with RARA overexpression. This supports our conviction in pursuing a doublet strategy in higher-risk MDS, where we are comparing tamibarotene and azacitidine to azacitidine alone. We remain steadfast in our commitment to delivering tamibarotene for the treatment of HR-MDS and look forward to sharing pivotal data from SELECT-MDS-1 by mid-fourth quarter.”

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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.