Miami, Florida--(Newsfile Corp. - July 8, 2024) - Fast-moving sectors need equally fast-moving companies, a box that Cybin Inc. (NYSE American: CYBN) (Cboe CA: CYBN) checks, supported by a June 26th update on progress made in fiscal 2024 ending on March 31st. In its presser, Cybin highlighted key advancements that strengthened its position as a leader in developing next-generation psychedelic-based therapeutics. Included is evidence that this Toronto-based clinical-stage biopharmaceutical company has and continues to make significant progress fueled by innovative research programs, robust financial health, and reaching strategic milestones aimed at addressing major depressive disorder (MDD) and generalized anxiety disorder (GAD).
For those just meeting Cybin Inc., it's essential to recognize that this company isn't following the traditional drug and treatment development trend. Instead, work to date has facilitated them blazing a trail to introduce a revolutionary approach to mental healthcare by using psychedelic-based compounds to bring transformative changes to how these conditions are treated. If successful, new doors of treatment could be opened to millions of patients worldwide who are resisting traditional treatments from drugs that can have unintended side effects worse than the condition treated.
A SEDI Insider Transaction report filed on June 28th shows that C-level executives, Directors, and stockholders close to the company are betting on achieving that success. They've voted that confidence with cash.
A Vote of Confidence Through Personal Investments
According to the SEDI filing on June 27th and 28th, 2024, multiple senior officers and directors, including CEO Douglas Drysdale, made substantial purchases of Cybin stock. These transactions include:
Aaron Frank Bartlone (Senior Officer): Purchased 200,000 shares at $0.2616 each, totaling $52,320.
Gregory Joseph Cavers (Senior Officer): Acquired 60,000 shares at $0.3687 each, amounting to $22,122.
Eric So (Chairman, President & CoFounder Various Holdings, including Family Trust and direct ownership): Made several purchases totaling over 250,000 shares at prices around $0.2548 each.
Gabriel Fahel (Senior Officer, Indirect Ownership): Bought over 100,000 shares across multiple transactions at prices ranging from $0.2532 to $0.35 per share.
Grant Bernard Froese (Director, Spouse's Holdings): Acquired 200,000 shares.
Paul Glavine (CoFounder, Director & CGO, Various Holdings Family Trust, Direct & Indirect Ownership): Purchased 145,200 shares at $0.2522 each, totaling $36,619.
These insider transactions, reflecting purchases in the public market, underscore the leadership's strong belief in Cybin's strategic direction and long-term potential. Moreover, these transactions often send a powerful signal to the market about the company's expected growth path and, as importantly, from an investor's perspective, the expectation for share price appreciation.
Zacks Rank Upgrade To BUY
Zacks Investment Research models in favor of the bullish case. In an updated report on July 5th, it upgraded Cybin Inc. to a Zacks Rank #2 (Buy), which it supports after factoring in the upward trend in earnings estimates, one of the most potent forces impacting stock prices and ratings. Notably, the Zacks rating system is based less on opinion than performance. According to its update about Cybin, it relies solely on the company's changing earnings picture, tracking EPS estimates for the current and following years from sell-side analysts through a consensus measure known as the Zacks Consensus Estimate.
The upgrade to Zacks Rank #2 reflects positivity about Cybin's earnings outlook, which they note could translate into buying pressure and an increase in its stock price. They support that assessment by pointing toward empirical research showing a strong correlation between trends in earnings estimate revisions and near-term stock movements. Zacks also supports its upgrade to Rank #2 (BUY) by highlighting that analysts have steadily raised their estimates for Cybin Inc.
Zacks Consensus Estimate for the fiscal year ending March 2025 expects a 52.6% improvement from the year-ago reported number. Evaluating a trend over the past three months, the Zacks Consensus Estimate for Cybin has increased by 15%, indicating growing confidence in Cybin's ability to post more robust financial results from strengthening the value of its operational deliverables.
Breakthrough Therapy Designation and Clinical Advances
One of Cybin's most notable achievements is the U.S. Food and Drug Administration (FDA) granting Breakthrough Therapy Designation (BTD) for CYB003, its proprietary deuterated psilocybin analog developed for the adjunctive treatment of MDD. This designation is a testament to the potential of CYB003 to significantly improve depressive symptoms and, as importantly for its path to market, provides expedited review and enhanced guidance from the FDA. So far, so good.
Cybin published positive topline results from the Phase 2 study of CYB003, which demonstrated a clinically significant reduction in depressive symptoms and emphasized the promise of this innovative treatment approach. What must undoubtedly be appreciated is that patients receiving CYB003 showed a mean reduction of 14 points in their MADRS score from baseline, with a substantial portion achieving remission from depression after just two doses. That score, enhanced by expedited FDA designations, shows that effective and safer treatment options with fewer side effects could be fast-tracked to the prescription pad mainstream.
That mission continues to advance. Cybin is preparing to launch its Phase 3 multinational study of CYB003 in the summer of 2024 after saying it has completed clinical site selection and ensuring that the upcoming trials will be conducted at 30 experienced sites across the United States and Europe. This pivotal study is designed to further evaluate the safety and efficacy of CYB003 in a larger MDD patient population. If endpoints are met, this Phase 3 trial would represent a significant milestone reached in the journey toward regulatory approval and commercialization.
CYB004 for Generalized Anxiety Disorder
More assets support the bullish thesis. In addition to CYB003, Cybin is advancing CYB004, its proprietary deuterated dimethyltryptamine (DMT) program targeting General Anxiety Disorder (GAD). Its initiation of a Phase 2 study of CYB004 represents a critical step towards establishing proof-of-concept for its efficacy in treating anxiety disorders. In another vote of interest, the FDA cleared Cybin's Investigational New Drug application for CYB004, further validating and acknowledging the potential of this compound.
The treatment shows that the FDA is willing to side with innovation- and a treatment path far less traveled. CYB004 induces acute psychedelic effects expected to last approximately 90 minutes following a single intramuscular dose, which Cybin says can become a highly scalable and intermittent treatment option for patients suffering from GAD. The company will have answers to questions by the end of 2024, with results that can provide crucial insights into the drug's efficacy, onset of effects, and long-term durability.
It's vital to include that Cybin's robust intellectual property portfolio enhances, supports, and protects its development mission for its treatment candidates. To date, the company has earned over 60 granted patents and more than 200 pending applications, an impressive IP arsenal that fortifies and maintains its competitive edge in the psychedelic therapeutics space. Noteworthy additions include a U.S. patent supporting the CYB003 program and patents in Canada and China for the CYB004 program. These patents ensure exclusivity until at least 2041, protecting Cybin's innovations and enabling sustained investment in their development.
Strategic Investments And Financial Stability
Additional excellent news for Cybin is that, financially speaking, it's well-capitalized to continue its groundbreaking work. As of March 31st, 2024, the company reported cash reserves totaling C$209 million (about USD$153 million). The successful closure of an oversubscribed private placement, which raised U.S.$150 million, demonstrated strong investor interest and confidence.
This, combined with the company's current cash position and at-the-market equity program, Cybin has access to over C$285 million (about USD$208 million) to advance its clinical programs and operational initiatives. Cybin also has strong leadership.
Leadership And Vision Are Additional Assets
Under the direction of CEO Doug Drysdale, the pace of advancing programs and initiatives is increasing, resulting from Cybin leveraging its evolution into a mature, late-stage biopharmaceutical company that can open development-related doors of opportunity more quickly. Once through, Drysdale's vision is simple to understand: transform the treatment paradigm for mental health disorders and improve patient and family outcomes. Focused on rigorous research, advancing novel clinical approaches, and leveraging robust regulatory engagement, that mission is making significant headway towards this goal, including completing the groundwork setting Cybin up to score several key milestones.
Nearest is initiating the Phase 3 study for CYB003, which is expected to be a significant event that could validate the compound's efficacy and safety on a larger scale. Similarly, the results from the Phase 2 study of CYB004 will be crucial in determining the viability of this treatment for GAD. These studies, ongoing regulatory engagement, and strategic partnerships support the bullish appraisals and growth models earned.
Still, it's important to note that as Cybin continues to push the boundaries of what is possible in psychedelic-based therapeutics, even these optimistic growth targets and ranking appraisals could prove conservative, especially if ongoing Phase 2 and Phase 3 trial results meet intended endpoints. The company, investors, and patients will have those answers this year.
About Cybin
Cybin is a clinical-stage biopharmaceutical company on a mission to create safe and effective psychedelic-based therapeutics to address the large unmet need for new and innovative treatment options for people who suffer from mental health conditions.
Cybin's goal of revolutionizing mental healthcare is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens. Cybin is currently developing CYB003, a proprietary deuterated psilocybin analog for the treatment of major depressive disorder and CYB004, a proprietary deuterated DMT molecule for generalized anxiety disorder and has a research pipeline of investigational psychedelic-based compounds.
Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For Company updates and to learn more about Cybin, visit www.cybin.com or follow the Company on X, LinkedIn, YouTube and Instagram.
Cautionary Notes and Forward-Looking Statements
Certain statements in this news release relating to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as "may", "should", "could", "intend", "estimate", "plan", "anticipate", "expect", "believe" or "continue", or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the Company's plans to progress to a Phase 3 trial of CYB003 in summer 2024; the release of topline Phase 2 CYB004 data around year-end 2024; the Company's ability to access capital under the ATM Program; and the Company's plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions.
These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; implications of disease outbreaks on the Company's operations; and the risk factors set out in each of the Company's management's discussion and analysis for the year ended March 31, 2024 and the Company's annual information form for the year ended March 31, 2024, which are available under the Company's profile on www.sedarplus.ca and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.
Cybin makes no medical, treatment or health benefit claims about Cybin's proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin's performance and operations.
Neither the Cboe Canada, nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.
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