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:

• Organigram Holdings (OGI), 2,042% surge in interest
• Celldex Therapeutics (CLDX), 1,941% surge in interest
• MacroGenics (MGNX), 764% surge in interest
• Krystal Biotech (KRYS), 439% surge in interest
• Matinas BioPharma (MTNB), 421% surge in interest
• Nanostring (NSTG), 279% surge in interest
• Fibrogen (FGEN), 190% surge in interest
• Summit Therapeutics (SMMT), 188% surge in interest
• Akebia Therapeutics (AKBA), 184% surge in interest
• Vertex Pharmaceuticals (VRTX), 162% surge in interest

Pipeline and key clinical candidates for these companies:

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.

Celldex is a clinical stage biotechnology company leading the science at the intersection of mast cell biology and the development of transformative therapeutics for patients. The company’s pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with severe inflammatory, allergic and autoimmune and other devastating diseases.

MacroGenics is a biopharmaceutical company focused on developing, manufacturing and commercializing monoclonal antibody-based therapeutics for the treatment of cancer. The company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics’ technology platforms and protein engineering expertise “has allowed the company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies,” MacroGenics states.

Krystal Biotech is a biotechnology company focused on developing and commercializing genetic medicines for patients with rare diseases. The company’s pipeline is based on its proprietary redosable HSV vector. In May, Vyjuvek was approved by the FDA for the treatment of dystrophic epidermolysis bullosa. Vyjuvek is a non-invasive, topical, redosable gene therapy designed to treat DEB at the molecular level.

Matinas BioPharma is a biopharmaceutical company focused on delivering therapies using its lipid nanocrystal platform delivery technology. Matinas’ lead LNC-based therapy is MAT2203, an oral formulation of the broad-spectrum antifungal drug amphotericin B, which although highly potent, can be associated with significant toxicity. MAT2203 was successfully evaluated in the completed Phase 2 EnACT study in cryptococcal meningitis, meeting its primary endpoint and achieving robust survival. MAT2203 will be further evaluated as an oral step-down monotherapy treatment following IV amphotericin B in a single pivotal Phase 3 study in the treatment of aspergillosis in persons with limited treatment options who are unable to be treated with azoles for reasons related to drug-drug interactions, resistance or for whom these antifungal agents are unable to be used for other clinical reasons.

NanoString Technologies says it offers “an ecosystem of innovative discovery and translational research solutions” to map the universe of biology – including the GeoMx Digital Spatial Profiler, the CosMx Spatial Molecular Imager and the AtoMx Spatial Informatics Platform. The CosMx SMI and AtoMx SIP platforms are expected to launch in 2022.

FibroGen is “committed to leveraging its expertise in connective tissue growth factor biology and hypoxia-inducible factor to discovering, developing, and commercializing a pipeline of first-in-class therapeutics for the treatment of unmet needs.” Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis, or IPF, locally advanced unresectable pancreatic cancer, metastatic pancreatic cancer, and Duchenne muscular dystrophy, or DMD. Roxadustat is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in CKD patients on dialysis and not on dialysis. Roxadustat is in Phase 3 clinical development in the U.S. and Europe for anemia associated with myelodysplastic syndromes, or MDS, and in Phase 3 clinical development in China for treatment of chemotherapy-induced anemia, or CIA.

Summit Therapeutics is initiating development activities for SMT112 and will do so first in NSCLC indications. Summit plans to start treating patients in clinical studies by the second quarter of 2023.

Akebia Therapeutics is a fully integrated biopharmaceutical company that says its purpose is “to better the lives of people impacted by kidney disease.”

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including sickle cell disease, beta thalassemia, APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes and alpha-1 antitrypsin deficiency.

Recent news on these stocks:

November 7

Celldex Therapeutics announced that it is proposing to offer and sell, subject to market conditions, shares of its common stock in an underwritten public offering. Celldex intends to use the net proceeds from the offering to continue clinical and preclinical development of its product candidates, including current and future development of barzolvolimab, growing its bispecific antibody platform and clinical candidates, funding ongoing efforts to develop additional clinical pipeline products and for general corporate purposes. Jefferies and Leerink Partners are acting as the joint book-running managers for the proposed offering.

Guggenheim upgraded MacroGenics to Buy from Neutral with a $12 price target following the company’s Q3 earnings report. The company’s Phase 2 TAMARACK study has completed enrollment ahead of schedule and the company now heads into “a nearer-term potential catalyst” in the first half of 2024, the analyst tells investors. In context of all this upcoming catalyst, as well as other developments and the company’s roughly $5.40 per share in cash and 2026 cash runway, the firm sees the risk-reward as “skewed to the upside from current levels.”

Matinas BioPharma announces positive results from an in vivo animal study of an oral LNC formulation of docetaxel, a well-known chemotherapeutic agent used in the management of multiple metastatic and unresectable tumors. Currently, docetaxel is administered intravenously and can be associated with significant side effects and toxicities. “We are excited to report new in vivo data demonstrating the therapeutic efficacy of an oral LNC formulation of docetaxel,” said Dr. James Ferguson, Chief Medical Officer of Matinas. “We believe this is a step forward for Matinas’ unique drug delivery platform, taking us beyond our successes in infectious disease by providing convincing proof-of-principle that orally administered LNCs can effectively target tumors and successfully deliver small molecule therapeutics to those tumors.” Key Findings: Efficacy: Anti-tumor effect of daily oral LNC docetaxel in both the high-dose and low-dose arms were comparable to IV docetaxel with statistically significant reductions in tumor volume compared with untreated controls at Day 14, and similar reductions in tumor weight at Day 14. Safety: No systemic toxicities were noted. Body weight was stable over treatment duration and hematologic parameters were similar to untreated controls.

Summit Therapeutics reported Q3 EPS of (3c) vs. (10c) last year. Q3 aggregate cash and cash equivalents, restricted cash, short-term investments, and receivables on September 30 totaled $200.5M as compared to $654.7M on December 31, 2022. “Our cash, cash equivalents, restricted cash, and short-term investments on September 30 was $198.9M as compared to $648.6M on December 31, 2022. Accounts receivable and research and development tax credits receivable on September 30, were $1.6M as compared to $6.1M on December 31, 2022. Our short-term investments consist of U.S. treasury securities. Our current notes payable balance at September 30 was $100M, which is due in September 2024.”

November 6

Organigram Holdings announced a C$124.6M follow-on strategic equity investment from BT DE Investments, a wholly-owned subsidiary of BAT (BTI). Subject to the receipt of certain regulatory approvals, approval from Organigram’s shareholders and other conditions, BAT will subscribe for 38.68M shares at a price of C$3.2203 per share, for gross proceeds of C$124.6M across three tranches. BAT will subscribe for 12.89M shares on the closing of the first tranche for gross proceeds of C$41.5M with the remaining 25.79M shares to be subscribed for in two further equal tranches on or around August 30, 2024 and February 28, 2025.

Krystal Biotech reported Q3 EPS of $2.79 vs ($1.17) last year, and Q3 revenue of $8.556M, consensus $6.37M. “The third quarter was highlighted by strong commercial execution of the VYJUVEK launch, advancement of the oncology program into the clinic and continued momentum in the CF program,” said Krish S. Krishnan, Chairman and CEO of Krystal Biotech. “With respect to the VYJUVEK launch, our guiding vision is centered around optimizing the patient experience, and we have and will continue to work tirelessly to ensure that each patient’s journey, with respect to starting on VYJUVEK and staying on it, is smooth, timely and hassle free.”

NanoString reported Q3 EPS of (78c), consensus (58c), and Q3 revenue of $48.1M, consensus $47.2M. “The last few months have been extraordinarily productive for our team. During the third quarter, we delivered record revenue while reducing our cash burn by nearly 50% sequentially,” said Brad Gray, President and CEO of NanoString. “In the early weeks of Q4, we took critical steps to transform our financial profile through a reorganization that helps support our march to breakeven, and sets us up to achieve our goal of a first full year of profitability in 2025.”

FibroGen reported Q3 EPS of (65c), consensus (68c), and Q3 revenue of $40.13M, consensus $36.84M. “Today, we reported another quarter of strong roxadustat volume growth in China, achieving the highest ever value share, at 42%, in the anemia of CKD category,” said Thane Wettig, Chief Executive Officer, FibroGen. “The continued strength of our China business, sooner than expected realization of our corporate cost reduction efforts and our strong balance sheet provide us a cash runway into 2026. Over the next 12 months, we will obtain data read-outs from our two late-stage pancreatic cancer trials, start a Phase 2 metastatic castrate-resistant prostate cancer trial, and file two immuno-oncology INDs. These unique and exciting programs, combined with the quality of our talented colleagues, provide a strong foundation to create significant value for shareholders relative to our current valuation.”

Vertex Pharmaceuticals reported Q3 EPS of $3.98, consensus $3.97. “Vertex has delivered another strong quarter across the business. We remain relentless in our commitment to reach more patients with our cystic fibrosis medicines, while preparing for the potential launch of exa-cel in multiple geographies,” said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. “Our R&D pipeline continues to make remarkable progress and we have a milestone-rich period coming up, with multiple major, near-term milestones, including completion of the Phase 3 pivotal trials for the vanzacaftor triple in cystic fibrosis and VX-548 in acute pain, as well as the Phase 2 VX-548 study data read-out in diabetic peripheral neuropathy.”

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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.