FDA Fast Track Status Could Send This Stock Flying

No typos here, folks. It's a groundbreaking approach that has yielded mind-blowing, life-altering results... [Image] In 2022, a staggering 3.1 million women battled breast cancer in the U.S. Brace yourself. By 2024, that number will skyrocket to a chilling 4 million. This ruthless disease reigns as the most prevalent cancer for women, second only to skin cancer. But wait, it doesn't discriminate against men either—just ask legendary KISS drummer Peter Criss, who faced his own fight in 2008. As global oncology spending soared from $90 billion to a staggering $190 billion in 2022, we yearn for breakthroughs beyond outdated chemo and radiation treatments, which have lingered for over half a century. Enter the fearless trailblazers, BriaCell Therapeutics Corp. (Nasdaq: BCTX, TSX: BCT). With FDA fast-track approval, they unleash an audacious secret weapon—breast cancer itself! No typos here, folks. It's a groundbreaking approach that has yielded mind-blowing, life-altering results. BriaCell Therapeutics Corp. (Nasdaq: BCTX, TSX: BCT) - 1-month trading range: $5.71 - 7.58 - Typical average daily volume: ~133,360 - Float: 11.08 million BriaCell Therapeutic’s Business Within the intricate realms of genetics, a formidable adversary lies in wait—cancer. This insidious disease emerges from altercations in our genes, dictating the growth division of our cells. Our cells continually replicate throughout our lifetimes, but errors can occur along the way. These errors may arise naturally, influenced by environmental factors like tobacco smoke or ultraviolet rays, or they can be inherited traits passed down through generations. Normally, our bodies possess mechanisms to eliminate damaged DNA cells before they develop into cancer. Unfortunately, as we age, this ability diminishes, leaving us more vulnerable to the onset of this disease. Contrary to foreign invaders like bacteria or viruses, cancer cells are no alien presence. They are, in fact, mutated versions of our own cells, which confuses our immune system, rendering it unable to recognize them as threats. This disguise allows cancer to evade detection and continue its assault on our well-being. Enter BriaCell, a groundbreaking innovator in the fight against breast cancer. Through their pioneering approach, they employ non-replicating breast cancer cells that are engineered to express specific proteins. These modified cells then trigger the production of GM-CSF, which stimulates the immune response. In simpler terms, BriaCell introduces cancer-like cells into the body, but with a critical alteration that prompts the immune system to perceive them as harmful. [The company has a cool little video that helps you visualize what’s happening.]( [1685111914--wr80bi.png] [Source: BriaCell website]( Hopefully, this immune recognition will instigate a search-and-destroy mission against breast cancer cells, bolstering our defense against the disease. BriaCell's achievements have not gone unnoticed. Their initial study, which earned them the FDA fast-track designation, showcased impressive overall survival rates ranging from 12 to 21 months for patients with metastatic breast cancer. This remarkable progress is undeniably significant, offering a glimmer of hope to those faced with limited time. Furthermore, BriaCell's treatment exhibits an advantage by not causing cross-resistance or overlapping toxicity when used alongside other treatment options. This compatibility enables it to complement existing therapies, potentially enhancing the effectiveness of overall cancer management. In addition to their flagship Bria-IMT and Bria-OTS treatments, BriaCell maintains a robust pipeline dedicated to tackling other types of cancer. [1685111914--7ha1tg.png] [Source: BriaCell Factsheet]( With their sights set on expanding their impact, they strive to bring newfound hope to individuals battling various forms of this devastating disease. On May 25th, the company announced BriaCell entered a definitive arrangement agreement for the spin-out of BriaPro Therapeutics Corp. Here’s what Dr. William V. Williams, BriaCell’s CEO, had to say about it: “As we focus our efforts on the upcoming pivotal study of our lead clinical candidate, Bria-IMT™, in advanced metastatic breast cancer, we believe that this strategy of spinning out certain pre-clinical immunotherapies in a separate entity of BriaPro Therapeutics Corp. will position them for success and will create our shareholder's value over the long term.” Financials With no approved and marketed drugs, BriaCell generates no revenue. Its current operating income stands at -$19.2 million for the trailing 12-month period, worse than -$15.3 million for 2022 and -$7.0 million in 2021. Total cash burn sits at -$15.6 billion for the trailing 12-month period, worse than -$12.5 million for 2022 and -$7.8 million in 2021. Luckily, the company is well capitalized, with $33.5 million in cash, down from $41 million in 2022 and $57.3 million in 2021. That’s helped the company keep from issuing any new shares since 2020. Promoter Activity I received an email from one promoter highlighting the company. Here are the five main points I got from their campaign: - An under-the-radar player in the oncology field, trading at an affordable price of around $6 per share. However, industry experts have set a staggering price target of nearly $25, suggesting a potential gain of over 300%. - BriaCell recently completed a strategic investment deal with Prevail Partners, LLC, securing $4 million in funding. Contract Research Organizations (CROs) rarely invest in small biotech firms. Prevail Partners' substantial investment demonstrates their confidence. - BriaCell's groundbreaking Bria-MT™ regimen has shown promising clinical value in patients with advanced metastatic breast cancer who have exhausted other treatment options. The treatment demonstrated robust clinical efficacy, better-than-expected survival outcomes, and an excellent safety profile earning it Fast Track status from the FDA - BCTX has a non-exclusive clinical trial collaboration with Incyte Corporation (NASDAQ: INCY) to evaluate combinations of novel clinical candidates. Such partnerships amplify BriaCell's reach and potential, offering opportunities for innovative therapies. Furthermore, BriaCell's small molecule program, centered around selective protein kinase C delta inhibitors, shows promise in pre-clinical models of various cancers and fibrotic diseases. - Breast cancer is the second leading cause of cancer-related deaths globally, affecting millions of lives annually. With BCTX's focus on enhancing the lives of individuals with limited therapy options through novel immunotherapies, investors can align their financial interests with a crucial mission. Overall, the promoter does a solid job of building a bullish case without sounding too sensational or over the top, though they don’t have any recent catalysts to speak of. For their efforts, they received $25,000 for a one-day campaign. Straight to the Facts Biotechs are right behind AI as the hottest sector to trade. Any PR about a favorable remark from the FDA, a study, or even FDA approval could send this stock soaring. It has a short interest of 12.5%, which is high enough to cause a pretty epic squeeze. Especially with how stubborn short-sellers have been lately. With the right news catalyst, it can run up to $12 until it meets resistance. Which would be a 100% move from here. I don’t know about you, but it sounds like a stock work putting on my watchlist. 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