Cytogel Pharma, LLC (Cytogel), a biopharmaceutical company dedicated to developing first-in-class, non-addictive treatments for moderate-to-severe pain, today announced the successful initial closing of its latest financing round, providing the necessary resources to initiate a Phase 2 clinical study for its lead therapeutic candidate, CYT-1010, with data read-out possible as early as year-end.

CYT-1010 represents a paradigm shift in pain management. By preferentially targeting specific pathways, the drug is designed to provide analgesic effects equivalent to or better than the leading opioids but without the debilitating side effects of respiratory depression, nausea, inflammation and high addiction rates associated with opioids.

Advancing a Transformational Approach to Pain Management

Cytogel is pioneering a novel class of therapeutics based on the endomorphin family of peptides. By preferentially targeting, with high precision, specific receptors in the central nervous system, the 6 transmembrane form of the mu receptor, CYT-1010 aims to deliver potent analgesic and anti-inflammatory effects, while avoiding the side effects of respiratory depression, nausea and addiction associated with traditional opioids.

Pre-clinical and Phase 1 studies with CYT-1010 demonstrated potent pain relief, rapid onset of action, anti-inflammatory effects, low abuse potential and no respiratory depression. The upcoming Phase 2 study is designed to evaluate the efficacy and safety of the compound in patients with acute post-operative pain, further validating the robust data seen in earlier developmental stages.

These findings position CYT-1010 as a potential breakthrough therapy and a meaningful alternative for patients and healthcare providers seeking safer, more effective pain management options. The Company will continue its capital raise to support additional clinical work. Cytogel has several US and international patents on its biotechnology and CYT-1010 represents the first iteration of a wide range of analgesic solutions the company believes can be generated by its
innovative technology.

Executive Commentary

“This financing is a vote of confidence in our science and our mission,” said Dean Maglaris, Chief Executive Officer of Cytogel. “We are now funded to conduct Phase 2 clinical development, a milestone for the Company, bringing us one step closer to delivering a potentially transformational, non-addictive solution to millions of patients and their physicians who currently have limited options for safe and effective pain relief. The results of our Phase 2 study will also position the company to initiate and consummate licensing arrangements for CYT-1010 with major pharmaceutical companies.”

Key Highlights of the Financing:

• Clinical Readiness: Proceeds will fund the initiation of a randomized, double-blind Phase 2
  study in acute post-operative pain, including site activation and patient enrollment.

• Operational Expansion: The capital will support the build-out of clinical operations
  infrastructure, including CRO engagement and regulatory submissions.

• Strategic Growth: This round includes participation from both existing stakeholders and
  new investors aligned with Cytogel’s mission to deliver safer alternatives to opiate-based
  pain management, while addressing the global pain crisis.

Addressing a Need in a $45 Billion Global Market

The financing arrives as the global post-operative pain management market is projected to reach $45.29 billion in 2026 and growing at a 5.7% CAGR through 2031, according to Mordor Intelligence.

Despite the scale of this market, healthcare providers remain caught between the 'gold standard' efficacy of opioids and the severe risks they pose, including respiratory depression, post-operative nausea, and potential for addiction and the development of Opioid Use Disorder (OUD). Recent data from the American Society of Anesthesiologists highlights an urgent need to modernize post-operative pain care, as more patients enter the operating room already managed for OUD, which underscores the urgency of developing non-addictive alternatives. CYT-1010 aims to fill this critical gap, offering a potent, non-addictive solution designed specifically for the hospital and ambulatory surgery center (ASC), settings where this need is most acute.

Regulatory Progress and Continued Capital Formation

“The scale of the opportunity and the social urgency of the opioid crisis demand that we move with even greater speed,” said Dean Maglaris. “We are preparing to enter a multi-billion-dollar market at a time when physicians, patients, and payers are all demanding alternatives.” The Company remains in discussions with additional strategic and institutional partners as it continues its capital formation efforts to support expanded clinical development.
Source: Mordor Intelligence: Post-Operative Pain Management Market Size and Share Report 2031 (February 2026)

About Cytogel Pharma
Cytogel Pharma is a clinical-stage biopharmaceutical company developing first-in-class drug candidates from the novel endomorphin family of molecules. These therapies are designed to target key pain pathways and provide effective pain relief while minimizing the risks associated with traditional opioid treatments. Cytogel’s lead investigational candidate, CYT-1010, has demonstrated safety and analgesic activity in a Phase 1 clinical trial, with preclinical data supporting its anti-inflammatory effects and potential across multiple pain indications. Cytogel is headquartered in Darien, CT with its R&D office based in Troy, NY.

Disclosure Notice:
CYT-1010 is an investigational new drug and has not been approved by the FDA or any regulatory body for use in humans or animals. This release contains forward-looking information about CYT-1010 and a potential new indication for the treatment of patients with moderate to severe post-operative pain via IV administration. Any potential benefits that may be implied by these statements involves substantial risks and uncertainties and actual results could differ materially from those expressed or implied by such statements, including, among other things, the possibility of unfavorable clinical trial results, unfavorable additional analyses of existing data; uncertainties regarding the commercial success of CYT-1010; the risk that regulatory authorities may require additional data or may deny approval altogether; rejection by the regulatory authorities of the design and results from our clinical studies; the possibility that any new drug applications for CYT-1010 may never be filed with regulatory authorities in any jurisdictions and, if filed, may never be approved in any jurisdictions or, if approved, could be severely limited by negative and restrictive labeling to the extent that commercial forecasts for CYT-1010 may never be realized.

Kimberly Weinrick
Cytogel
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As we close out 2025, I want to take a moment to reflect on the remarkable shifts we are witnessing across medicine, markets, and patient care, and how they are impacting our mission at Cytogel Pharma.

This year, Eli Lilly became the first healthcare company to surpass a $1 trillion market valuation, a historic milestone fueled by long-term investment in scientific innovation and the rapid growth of its therapeutic platforms, Mrinalika Roy of Reuters provided an interesting update. The company’s recent acquisition of SiteOne Therapeutics to expand its pain pipeline further signals something powerful: breakthrough science in pain management is gaining the investment and visibility it has long deserved. This momentum is more than financial. It’s a reflection of evolving public health priorities.

On a related front, a recent Rolling Stone article underscored a growing crisis: the rise of nitazenes, synthetic opioids that are up to nine times stronger than fentanyl, which are now increasingly found in counterfeit pills and street drug supplies. These substances are hard to detect and far more lethal, creating a hidden epidemic within an already devastating opioid crisis. The case for safer, science-driven pain solutions has never been stronger.

At Cytogel Pharma, we believe these are strong signals that it is time for development of transformational options for pain treatment. We are pursuing a fundamentally different approach through our investigational medicine, CYT-1010, a first-in-class endomorphin therapy with the potential to provide effective analgesia without the severe risks of respiratory depression or addiction. In Phase 1, CYT-1010 demonstrated safety, rapid onset of action, and compelling analgesic activity. Preclinical data further support its anti-inflammatory effects and potential use in acute post-surgical pain, and other conditions.

As CYT-1010 enters Phase 2 clinical development in 2026, we do so with momentum behind us, both from our own data and discoveries, along with those from the broader scientific and investment communities that increasingly share our belief: Pain care must evolve. Lives depend on it.

We enter the new year with purpose, gratitude, and determination to bring a safer future in pain care within reach.

Warm wishes for a healthy and hopeful 2026,

C. Dean Maglaris
CEO, Cytogel Pharma

DARIEN, Conn., November 20, 2025-- Cytogel Pharma, a clinical-stage biopharmaceutical startup pioneering first-in-class endomorphin-based therapies, announced today that it is progressing its equity financing round to advance development of its lead compound, CYT-1010®, into Phase 2 clinical trials. CYT-1010 is the first member of a new class of drugs, the endomorphins, to reach clinical development, representing a transformative approach to relieve pain and overcome the limitations of traditional opioids.

CYT-1010 acts through a novel mechanism of action on the truncated form of the mu-opioid receptor (MOR) to deliver potent, targeted pain relief. Unlike classical opioids, CYT-1010 is derived from the endomorphins, which are naturally produced in the human brain. They preferentially activate the truncated MORs in the central nervous system that block pain while avoiding the unwanted adverse effects such as respiratory depression and addiction potential.

Following a successful Phase 1 clinical trial demonstrating safety and analgesic activity in humans, Cytogel is preparing to initiate Phase 2 clinical development. Research has shown that CYT-1010 provides three-to-four times more potent pain relief than morphine, along with strong anti-inflammatory benefits, substantially reduced abuse potential, and profoundly reduced respiratory depression.

“CYT-1010 represents a potential turning point in the treatment of moderate to severe pain,” said C. Dean Maglaris, Chairman and Chief Executive Officer of Cytogel Pharma. “Our goal has always been to create a medicine that provides safe, effective pain relief without the devastating side effects associated with traditional opioids. With strong scientific validation, a clear path into Phase 2, and the continued confidence of our investors and board, we are well-positioned to deliver on that vision.”

In breakthrough preclinical research, an analog of CYT-1010 demonstrated anti-inflammatory effects, reducing recovery time by 50%-75% fewer days in cases of inflammatory and post-operative pain.

Cytogel’s funding will support Phase 2 clinical trials and expanding studies toward additional indications where the company’s platform technology may offer a safer, more effective path forward for millions living with pain. The U.S. Trademark Certificate of Registration has been issued for CYT-1010®. Cytogel also holds a robust portfolio of issued patents and patent applications covering multiple compositions and uses.

Cytogel extends appreciation to its Board of Directors for their leadership and commitment: C. Dean Maglaris Chairman & CEO, Jerry Leamon, Frederick Telling, PhD, Eric Lang, MD, Mike Ullmann, Steven G. Chrust, Cassandra Klimp as well as luminaries across the medical, scientific, and advocacy communities who serve on Cytogel’s Advisory Board.

About Cytogel Pharma
Cytogel Pharma, LLC is a clinical-stage biopharmaceutical startup developing first-in-class drug candidates from the novel endomorphin family of molecules that target key pain pathways. The company’s groundbreaking approach offers a new mechanism of action distinct from traditional opioids, with the goal of providing potent, safe, and non-addictive pain relief for patients worldwide.

Disclosure Notice
CYT-1010 is an investigational new drug and has not been approved by the FDA or any regulatory body for marketing or for clinical treatment of humans or animals. This release contains forward-looking information about CYT-1010 and a potential new indication for the treatment of patients with moderate to severe post-operative pain via IV administration. The realization of any potential benefits involves substantial risks and uncertainties that could cause actual
results to differ materially from those expressed or implied by such statements.

We are encouraged by the growing momentum across the pain management landscape. Eli Lilly’s recent acquisition of SiteOne Therapeutics to expand its pain pipeline signals a clear shift in priorities, one that favors safer pain treatments and innovative science-driven solutions.

Earlier this year, the FDA approval of JOURNAVX (suzetrigine) by Vertex Pharmaceuticals marked a significant step forward. As the first new class of pain treatment approved in more than 20 years, this forward motion illustrates what is possible when innovation, rigorous science and patient needs align. It also highlights the medical community’s increasing readiness to embrace alternatives that manage pain effectively without the risks of addiction and respiratory depression.

At Cytogel Pharma, we view these milestones as a strong validation of the path we are on. Acute and chronic pain are rising, and the demand for safer, non-addictive treatments that offer effective pain relief has never been more urgent. We are committed to advancing CYT-1010 as part of the next generation of pain solutions rooted in both efficacy and safety.

CYT-1010 is the first investigational medicine from a new class of drugs known as endomorphins. It is designed to deliver potent pain relief while minimizing the risks commonly associated with traditional opioids. In preclinical studies, CYT-1010 has also demonstrated robust anti-inflammatory effects and a compelling safety profile. In a Phase 1 trial, it showed a rapid onset of action and meaningful analgesia, further supporting its potential as a transformational therapy.

As we move into Phase 2 clinical development, our focus remains clear: to bring forward innovative, patient-centered treatments that resolve pain with substantially fewer side effects. We are grateful to the scientific community, our research collaborators, and our investors for their continued support.

We believe that patients and providers are demanding a new standard in pain care, and we are proud to be part of that transformation.

With determination and optimism,

Dean Maglaris
Chief Executive Officer
Cytogel Pharma

DARIEN, CT, December 16, 2024 — Cytogel Pharma, a clinical stage biopharmaceutical company dedicated to developing innovative pain management solutions, announces the appointment of Dr. Eric Lang to its Board of Directors. Dr. Lang brings more than 25 years of extensive experience in the pharmaceutical industry, with a deep background in drug and device development across multiple therapeutic areas.

Dr. Lang's career includes pivotal roles at industry leaders including Johnson & Johnson, Novartis, and several other prominent pharmaceutical companies. His expertise in guiding development programs from early translational stages through successful regulatory filings, including multiple INDs and NDAs, will be invaluable as Cytogel advances its lead compound, CYT-1010, into Phase 2 clinical development.

"Dr. Lang's appointment comes at a crucial time as CYT-1010navigates through significant clinical milestones. His profound understanding of the pharmaceutical landscape and commitment to advancing patient care align perfectly with our mission," said Dean Maglaris, CEO of Cytogel. "We are already leveraging Dr. Lang’s insights and leadership as we work towards transforming pain management."

CYT-1010 is a pioneering endomorphin compound targeting the central nervous system to block pain with minimal adverse effects. It represents a potential transformational alternative to traditional pain treatments, with substantially reduced addiction potential and lower risk of respiratory depression. The drug's development aligns with Cytogel's commitment to addressing the urgent need for safer, non-addictive pain relief options.

In addition to his role at Cytogel, Dr. Lang actively contributes to the medical and academic community, continuing his involvement in various non-profit and advisory capacities. His leadership extends beyond the boardroom into impactful community and global health initiatives.

Cytogel Pharma remains at the forefront of developing cutting-edge technologies and therapeutic solutions, supported by a strong portfolio of issued patents. As CYT-1010 advances into the next phase of clinical trials, Dr. Lang's expertise will play a critical role in steering its development towards commercial success and broad patient access.

In addition to Eric Lang, MD, Michael Ullmann former EVP and General Counsel at J&J, along
with Jerry Leamon, Former Deloitte Executive have recently joined the Cytogel Board of Directors. Luminaries across medical, scientific, and advocacy communities also serve on Cytogel’s Board of Advisors, including: The Honorable Chris Christie, Former Governor of New Jersey, Retired U.S. Army Major General Gale Pollock, The Honorable Patrick J. Kennedy, former U.S. Congressman from Rhode Island, Professor A. Thomas McLellan, PhD., former Deputy Director, White House Office on National Drug Control Policy ; and Paul Mango, Former Deputy Chief of Staff at the U.S. Department of Health and Human Services. Each leader is helping to advocate for safer & non-addictive pain management as CYT-1010 is entering Phase 2 Clinical Trials.

Furthermore, the U.S. Trademark Certificate of Registration has been issued for Cytogel’s, CYT- 1010®. Cytogel also has a solid portfolio of issued patents and patent applications claiming multiple compositions and uses.

For more information about Cytogel Pharma and the development of CYT-1010, please visit the website and follow Cytogel Pharma on LinkedIn.

About Cytogel

Cytogel Pharma is a clinical stage biopharmaceutical company focused on the development of novel therapies intended to significantly improve the treatment landscape for patients suffering from moderate to severe pain. The company’s innovative approach aims to deliver safe and effective solutions that can address and mitigate the risks associated with conventional pain medications.

Disclosure Notice: CYT-1010 is an investigational new drug and has not been approved by the FDA or any regulatory body for use in humans or animals. This release contains forward-looking information about CYT-1010 and a potential new indication for the treatment of patients with moderate to severe post-operative pain via IV administration. The realization of any potential benefits involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.

DARIEN, CT., June 24, 2024 – Cytogel Pharma, a clinical stage biopharmaceutical company dedicated to developing first-in-class drug candidates for safer pain management, proudly announces the appointment of Michael Ullmann to its Board of Managers. Mr. Ullmann, who recently retired after serving as Executive Vice President and General Counsel at Johnson & Johnson (JNJ), brings a wealth of experience and strategic acumen to the Cytogel team.

During his distinguished tenure at JNJ, Mr. Ullmann was instrumental in guiding the company through numerous high-profile challenges, significantly contributing to its growth and success. His leadership helped grow JNJ’s market cap from $177 billion to $450 billion and sales to $94 billion. His extensive experience in managing complex legal, regulatory, and business issues across global markets makes him a highly valued addition to Cytogel's leadership.

"We are delighted to welcome Michael Ullmann to our Board of Managers," said Dean Maglaris, CEO of Cytogel Pharma. "His deep knowledge of the healthcare industry and his proven success in guiding a leading global healthcare company through myriad challenges will be invaluable to the Company as we advance CYT-1010 through clinical development and towards commercial success."

Mr. Ullmann's role at JNJ encompassed significant achievements in M&A and corporate governance, making him a pivotal player in the company’s strategy and execution. His commitment to ethical leadership and corporate responsibility aligns seamlessly with Cytogel Pharma’s mission to provide safe and effective pain management solutions.

“I am excited to contribute to Cytogel at this pivotal time," said Mr. Ullmann. "The potential of CYT-1010 to provide safer, non-addictive pain relief is particularly important, and I look forward to working with the team to realize this vision, transforming the landscape of pain management and enhancing patient care.”

Mr. Ullmann also continues to share his expertise in the non-profit sector, serving on several boards, including Americares and the Princeton Area Community Foundation. His broad experience and leadership in healthcare and beyond will support Cytogel’s goals to innovate within the pain management sector and to expand its reach and impact.

Mr. Maglaris added, “We are excited for the insights and leadership Mr. Ullmann will bring to Cytogel as CYT-1010 progresses into Phase 2 clinical development. His guidance will be crucial as we seek alternatives to existing opioid treatments in pain management."

In addition to Michael Ullmann, Jerry Leamon, Former Deloitte Executive has recently joined the Board of Managers and luminaries across medical, scientific, and advocacy communities serve on Cytogel’s Board of Advisors, including: The Honorable Chris Christie, Former Governor of New Jersey, Retired U.S. Army Major General Gale Pollock, The Honorable Patrick J. Kennedy, former U.S. Congressman from Rhode Island, Professor A. Thomas McLellan, PhD., former Deputy Director, White House Office on National Drug Control Policy ; and Paul Mango, Former Deputy Chief of Staff at the U.S. Department of Health and Human Services. Each leader is helping to advocate for safer & non-addictive pain management as CYT-1010 is entering Phase 2 Clinical Trials.

Furthermore, the U.S. Trademark Certificate of Registration has been issued for Cytogel’s, CYT-1010®. Cytogel also has a solid portfolio of issued patents and patent applications claiming multiple compositions and uses.

The opioid crisis in America is an epidemic and it has now risen to the attention of the U.S. Supreme Court, as the Nation’s highest court rules on the settlements of opioid lawsuits. An unintended consequence of this heightened attention is to dissuade scientific and clinical developers from the analgesic category, discouraging development of new pain medications that might actually break the cycle of addiction and overdose deaths, giving patients safe, effective pain relief; thereby effectively addressing the opioid crisis.

“In this environment it is imperative to pursue development of drugs that won’t contribute to the addiction crisis, novel drugs that are highly effective pain relievers and importantly safer, devoid of addiction potential and other serious adverse effects. This is Cytogel’s strategy.”

— C. Dean Maglaris, CEO of Cytogel

DARIEN, CONN., USA, August 23, 2023 /EINPresswire.com/ – Cytogel Pharma is dedicated to developing drug candidates derived from substances produced by the human brain for the safer management of moderate to severe pain. This innovative strategy has led to their primary drug candidate, CYT-1010, a novel analgesic with potential to provide relief from moderate to severe pain while avoiding addiction and respiratory depression.

“In spite of the lawsuits and settlements, there remains an important and urgent opportunity to eliminate the destructive addictions from opioid use by conducting new research and development of innovative, safer pain treatment solutions,” stated C. Dean Maglaris, CEO of Cytogel. “CYT-1010 has demonstrated effects that provide significant relief from pain while avoiding addiction and respiratory depression.”

• Sabrena Moreno wrote in “Health – Axios” (April 21, 2023) that the well-intended attempts to crack down on opioid prescribing hasn’t stopped overdoses from rising but has had the unintended effect on patients with chronic pain, who say the result has been harder-to-fill prescriptions and heightened withdrawal and suicide risks.

• Crucially: The U.S. continues to grapple with how to address the addiction crisis while also helping hundreds of millions of Americans with chronic pain. Meanwhile both public health issues continue to get worse.

A safer drug, one without addiction potential and capable of providing potent pain relief, could effectively address the crisis while responding to the need for adequate relief from moderate to severe pain. Cytogel’s CYT-1010 has the potential to become the breakthrough that this crisis demands.

CYT-1010 is an endomorphin compound that targets receptors of the central nervous system to block pain, with minimal adverse effects: In a Phase 1 clinical study, CYT-1010 demonstrated safety from serious adverse events and significant analgesic activity. In preclinical studies, at therapeutic doses, it has been shown to provide:

• Safe and effective pain relief

• Impressive anti-inflammatory effects

• Little to no addiction potential

• No respiratory depression

This groundbreaking approach is backed by scientific evidence that elucidates the novel mechanism of action of CYT-1010, differentiating it from the existing opioids and presenting an attractive alternative treatment for people in pain. As well, the U.S. Department of Defense’s Institute for Surgical Research indicated their interest in CYT-1010 by recently issuing Cytogel a Cooperative Research and Development Agreement (CRADA) to further study CYT-1010’s potential.

Former Congressman Patrick Kennedy, advisor to Cytogel and a leading and long-standing advocate for improved substance use care, says “With its alternative to classical opioid treatment, Cytogel is on the cusp of a major medical breakthrough—one that will quite literally save lives,” said Kennedy. “We need all hands-on-deck when it comes to battling the public health crisis of addiction. I’m proud to work with a company that is hyper-focused on changing the status quo.”

Similar sentiments were expressed by Dr. A. Thomas McLellan, a career researcher in addiction and former Deputy Director of the White House Office of Drug Control Strategy. McLellan noted that “a highly effective analgesic that is non-addictive has been considered the holy grail of medicine for over a century; with CYT-1010, Cytogel seems to have discovered it.”

Furthermore, the U.S. Trademark Certificate of Registration has been issued for Cytogel’s, CYT-1010®. Cytogel also has a solid portfolio of issued patents and patent applications claiming multiple compositions and uses.

About Cytogel Pharma:
Cytogel Pharma is a clinical stage biopharmaceutical company focused on developing novel endomorphin molecules for treating moderate to severe pain, that could avoid the serious side effects of existing opioids and other analgesics.

The Company’s lead product candidate is CYT-1010, an endomorphin analog, with a novel mechanism of action that in pre-clinical studies and one clinical study, has shown fewer of the serious side effects of the classical opioids. It is currently being developed for use in treating post-operative pain, by IV administration.

Disclosure Notice:
CYT-1010 is an investigational new drug and has not been approved by the FDA or any regulatory body for use in humans or animals. This release contains forward-looking information about CYT-1010 and a potential new indication for the treatment of patients with moderate to severe post-operative pain via IV administration. Any potential benefits that may be implied by these statements involves substantial risks and uncertainties and actual results could differ materially from those expressed or implied by such statements, including, among other things, the possibility of unfavorable clinical trial results, unfavorable additional analyses of existing data; uncertainties regarding the commercial success of CYT-1010; the risk that regulatory authorities may require additional data or may deny approval altogether; rejection by the regulatory authorities of the design and results from our clinical studies; the possibility that any new drug applications for CYT-1010 may never be filed with regulatory authorities in any jurisdictions and, if filed, may never be approved in any jurisdictions or, if approved, could be severely limited by negative and restrictive labeling to the extent that commercial forecasts for CYT-1010 may never be realized.

DARIEN, CONNECTICUT, USA, July 17, 2023 — Cytogel Pharma, a clinical stage biopharmaceutical company developing first-in-class drug candidates for safer pain management, announces the appointment of Jerry Leamon to its Board of Managers. In his more than 30-year career with Deloitte, Mr. Leamon has held a variety of leadership positions including as Global Managing Director responsible for the strategic direction of the firm’s businesses worldwide, and ten years as a leader on its M&A practice.

Today, Mr. Leamon serves on boards helping to drive strategy across multiple channels, engaging multiple stakeholders. Working through varying and complex landscapes, including banking and healthcare, Mr. Leamon drives actionable solutions. He is an advocate for safer & non-addictive pain management, such as CYT-1010, an alternative to classical opioids.

CYT-1010, an endomorphin compound, elucidates a novel mechanism of action, has demonstrated effective pain relief with no respiratory depression and little to no addiction potential. CYT-1010 is differentiated from the existing opioids and presents a safer alternative treatment for people in pain.

Recently it was announced that Cytogel has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Army Institute of Surgical Research (USAISR), to cooperate in a groundbreaking research and development project, “The evaluation of Cytogel’s novel analgesic, CYT-1010, for battlefield injury-induced pain”.

“It is my distinct privilege to welcome Jerry Leamon to our Board of Managers. His deep understanding of multifaceted companies through his extensive board work will be an asset to me and our Company, as we drive CYT-1010 through clinical development and, ultimately, toward revenue generation.” said Dean Maglaris, CEO of Cytogel. "As a driver of strategic change, Jerry will help advance our mission of providing a non-addictive, safe and effective option for pain management. He joins us at this critical time as we take CYT-1010 into phase 2 clinical development.”

Following his very successful career with Deloitte, Mr. Leamon is an active leader for several firms as board member and board chair, including: Chairman of the Board of Directors for Korn Ferry, where he previously chaired the compensation committee and was a member of the audit committee. He has been a member of the Korn Ferry Board since 2012.

Additionally, Mr. Leamon is a Member of the Board and Chairman of the audit committee for Credit Suisse USA pending its upcoming merger with UBS, as well as Member of the Board of Geller & Co., a private company composed largely of multi-family ultra-high net worth investment and advisory businesses.

Mr. Leamon is also the audit committee Chair for Jackson Hewitt Tax Services, a private equity owned business, and Member of the Business Advising Council of the Carl H. Lindner School of Business at the University of Cincinnati.

Previously he served as chairman of the Americares Foundation for seven years and a board member for 17 years, as well as Trustee Emeritus of the University of Cincinnati Foundation.

“I’m delighted to bring my strategic and M&A experience to helping Cytogel achieve its critical mission.” explained Mr. Leamon. “It’s terrific to work with Dean Maglaris and the Cytogel team on the very important development of a safer, novel treatment for pain, that greatly reduces the risk of addiction and respiratory depression for patients.”

In addition to Jerry Leamon, luminaries across medical, scientific and advocacy communities have recently joined Cytogel’s Board of Advisors, including: The Honorable Chris Christie, Former Governor of New Jersey, Retired U.S. Army Major General Gale Pollock, The Honorable Patrick J. Kennedy, former U.S. Congressman from Rhode Island, Professor A. Thomas McLellan, PhD., former Deputy Director, White House Office on National Drug Control Policy; and Paul Mango, Former Deputy Chief of Staff at the U.S. Department of Health and Human Services. Each leader is helping to advocate for safer & non-addictive pain management as CYT-1010 is entering Phase 2 Clinical Trials.

Furthermore, the U.S. Trademark Certificate of Registration has been issued for Cytogel’s, CYT-1010®. Cytogel also has a solid portfolio of issued patents and patent applications claiming multiple compositions and uses.

About Cytogel Pharma:
Cytogel Pharma is a clinical stage biopharmaceutical company focused on developing novel endomorphin molecules for treating moderate to severe pain, that could avoid the serious side effects of existing opioids and other analgesics.

The Company’s lead product candidate is CYT-1010, an endomorphin analog, with a novel mechanism of action that in pre-clinical studies and one clinical study, has shown fewer of the serious side effects of the classical opioids. It is currently being developed for use in treating post-operative pain, by IV administration.

Disclosure Notice:
CYT-1010 is an investigational new drug and has not been approved by the FDA or any regulatory body for use in humans or animals. This release contains forward-looking information about CYT-1010 and a potential new indication for the treatment of patients with moderate to severe post-operative pain via IV administration. Any potential benefits that may be implied by these statements involves substantial risks and uncertainties and actual results could differ materially from those expressed or implied by such statements, including, among other things, the possibility of unfavorable clinical trial results, unfavorable additional analyses of existing data; uncertainties regarding the commercial success of CYT-1010; the risk that regulatory authorities may require additional data or may deny approval altogether; rejection by the regulatory authorities of the design and results from our clinical studies; the possibility that any new drug applications for CYT-1010 may never be filed with regulatory authorities in any jurisdictions and, if filed, may never be approved in any jurisdictions or, if approved, could be severely limited by negative and restrictive labeling to the extent that commercial forecasts for CYT-1010 may never be realized.

DARIEN, CONNECTICUT, USA, May 16, 2023 -- Cytogel Pharma Enters into CRADA with the U.S. Army Institute of Surgical Research, to cooperate in a research and development project, “The evaluation of Cytogel’s novel analgesic, CYT-1010, for battlefield injury-induced pain”.

Cytogel Pharma, LLC. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented endomorphin family of endogenous compounds, announced today that it has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Army Institute of Surgical Research (USAISR).

This work is in support of the requirement to develop and evaluate improved analgesic medications that deliver effective pain relief and are free of performance-limiting side effects. There is an acute need for an efficacious, shelf-stable, easily administered battlefield analgesic with minimal side effects.

Cytogel has developed a new class of analgesics, the endomorphins. One of those, CYT-1010, is a highly selective mu opioid receptor (MOR) agonist with a unique chemical structure and novel mechanism of action that involves preferential binding to the truncated splice variants of the MOR initiated at Exon 11 that produce analgesic effects with reduced side effects. CYT-1010 is highly stable and demonstrated to be more potent than morphine in animal pain models. Further, it possesses anti-inflammatory effects, and has reduced side effects including no significant nausea/vomiting, no respiratory depression, at doses up to 9-fold the effective dose for pain relief, and little to no reward in animal testing, indicating a relative lack of addiction potential. CYT-1010 is not a precursor for, or convertible to, any current opioid drug or related drug of abuse which should support a less restrictive DEA classification. Pre-clinical and phase 1 human acute pain models of CYT-1010 suggest analgesic properties for several types of pain (e.g., acute, neuropathic, inflammatory).

“This research and development agreement with USAISR, an evaluation of Cytogel’s technology, is occurring as we prepare to begin phase 2 clinical testing of CYT-1010 to provide a non-addictive, safe and effective option for pain management” said Dean Maglaris, CEO of Cytogel Pharma.

About Cytogel Pharma:
Cytogel Pharma is a clinical stage biopharmaceutical company focused on developing promising early-stage, novel products from the endomorphin family of molecules for the treatment of moderate to severe pain, that could avoid the serious side effects of existing opioids and other analgesics.
The Company has identified and protected a number of product candidates that hold promise for success in this arena. Its lead product candidate is CYT-1010, an endomorphin 1 analog, an atypical analgesic with a demonstrated novel mechanism of action that in pre-clinical studies and one early clinical study, has shown fewer of the serious side effects of the classical opioids. This groundbreaking approach is backed by scientific evidence that differentiates it from the existing opioids and presents an attractive alternative treatment for people in pain. It is currently being developed for use in treating post-operative pain, by IV administration.

Disclosure Notice:
CYT-1010 is an investigational new drug and has not been approved by the FDA or any regulatory body for use in humans or animals. This release contains forward-looking information about CYT-1010 and a potential new indication for the treatment of patients with moderate to severe post-operative pain via IV administration. Any potential benefits that may be implied by these statements involves substantial risks and uncertainties and actual results could differ materially from those expressed or implied by such statements, including, among other things, the possibility of unfavorable clinical trial results, unfavorable additional analyses of existing data; uncertainties regarding the commercial success of CYT-1010; the risk that regulatory authorities may require additional data or may deny approval altogether; rejection by the regulatory authorities of the design and results from our clinical studies; the possibility that any new drug applications for CYT-1010 may never be filed with regulatory authorities in any jurisdictions and, if filed, may never be approved in any jurisdictions or, if approved, could be severely limited by negative and restrictive labeling to the extent that commercial forecasts for CYT-1010 may never be realized.

Cytogel Pharma announced the appointment of Chris Christie, the 55th Governor of the State of New Jersey, to its Advisory Board.

DARIEN, CONNECTICUT, USA, April 18, 2023 — Cytogel Pharma, a clinical stage biopharmaceutical company developing first-in-class drug candidates for safer pain management, announced the appointment of the Honorable Chris Christie, the 55th Governor of the State of New Jersey, to its Advisory Board. During his two terms in office, Governor Christie emphasized many important health issues including the opioid crisis. In 2017, Governor. Christie was appointed Chairman of the President’s Commission on Combating Drug Addiction and the Opioid Crisis, issuing a final report with more than 65 substantive recommendations. He is an advocate for safer & non-addictive pain management, such as CYT-1010, an alternative to classical opioids.

CYT-1010, an endomorphin compound, elucidates a novel mechanism of action, has demonstrated effective pain relief with no respiratory depression and little to no addiction potential. CYT-1010 is differentiated from the existing opioids and presents a safer alternative treatment for people in pain.

“Governor Christie has driven bipartisan attention toward achieving solutions to combat addiction from pain medications and other substances. It is a privilege to welcome Governor Christie to our esteemed Advisory Board,” said Dean Maglaris, CEO of Cytogel. "As a highly effective leader and dynamic catalyst for change, Governor Christie will help advance our mission of providing a non-addictive, safe and effective option for pain management. Governor Christie joins us at this critical time as we take CYT-1010 into phase 2 clinical development.”

Prior to his service as Governor, Mr. Christie served as the United States Attorney for the District of New Jersey from January 2002 to December 2008. His office prosecuted 130 cases of political corruption at all levels of New Jersey government and never lost a case. He served as one of seventeen U.S. Attorneys on the Attorney General’s Advisory Committee in Washington, DC.

He was in the private practice of law from 1987-2001 specializing in corporate law, securities matters and appellate advocacy. Mr. Christie graduated from the University of Delaware with a B.A. in Political Science in 1984. He was awarded a Juris Doctor degree by Seton Hall University School of Law in 1987, and is admitted to the Bar of the State of New Jersey, the U.S. District Court of New Jersey, and the United States Supreme Court.

In 2019, Governor Christie authored The New York Times best seller, Let Me Finish, about his life and career in New Jersey and as a candidate for President. In 2021, he authored the book, Republican Rescue, on the future of the Republican Party after the losses during the Trump years. Governor. Christie is now a Senior Legal and Political Commentator for ABC News and the Managing Member of the Christie Law Firm and Christie 55 Solutions, LLC in Morristown, NJ.

Governor Christie also serves on the boards of Pacira Pharmaceuticals in Parsippany, NJ, LifePoint Health in Nashville, TN, Saker Holdings in Middletown, NJ, Maxim Crane in Bridgeville, PA., and the Board of Directors of the New York Mets, appointed by owner Steve Cohen.

“Across the country and around the world, we understand the tragic increases in opioid fatalities but so far have been unsuccessful in stemming this pandemic, as the fatalities continue to rise. We must intensify efforts, at many levels and through multiple means, to beat this scourge. A cornerstone, foundational piece, is to find safe solutions for pain treatment and reduce or eliminate the use of addictive opioids. With Cytogel’s innovative CYT-1010, an alternative to classical opioid treatment, we are working hard to provide life-saving options at this critical time,” explained Former Governor Christie. “I’m proud to work with Dean Maglaris and the Cytogel team on the very exciting development of a safer, novel treatment for pain, that avoids the path to addiction.”

In addition to Governor Christie, luminaries across medical, scientific and advocacy communities have recently joined Cytogel’s advisory board, including: Retired U.S. Army Major General Gale Pollock, Honorable Patrick J. Kennedy, former U.S. Congressman, Professor A. Thomas McLellan, PhD., former Deputy Director, White House Office on National Drug Control Policy; and Paul Mango, Former Deputy Chief of Staff at the U.S. Department of Health and Human Services. Each leader is helping to advocate for safer & non-addictive pain management as CYT-1010is entering Phase 2 Clinical Trials.

Furthermore, the U.S. Trademark Certificate of Registration has been issued for Cytogel’s, CYT-1010®. Cytogel also has a solid portfolio of issued patents and patent applications claiming multiple compositions and uses.

About Cytogel Pharma:
Cytogel Pharma is a clinical stage biopharmaceutical company focused on developing novel endomorphin molecules for treating moderate to severe pain, that could avoid the serious side effects of existing opioids and other analgesics.

The Company’s lead product candidate is CYT-1010, an endomorphin analog, with a novel mechanism of action that in pre-clinical studies and one clinical study, has shown fewer of the serious side effects of the classical opioids. This It is currently being developed for use in treating post-operative pain, by IV administration.

Disclosure Notice:
CYT-1010 is an investigational new drug and has not been approved by the FDA or any regulatory body for use in humans or animals. This release contains forward-looking information about CYT-1010 and a potential new indication for the treatment of patients with moderate to severe post-operative pain via IV administration. Any potential benefits that may be implied by these statements involves substantial risks and uncertainties and actual results could differ materially from those expressed or implied by such statements, including, among other things, the possibility of unfavorable clinical trial results, unfavorable additional analyses of existing data; uncertainties regarding the commercial success of CYT-1010; the risk that regulatory authorities may require additional data or may deny approval altogether; rejection by the regulatory authorities of the design and results from our clinical studies; the possibility that any new drug applications for CYT-1010 may never be filed with regulatory authorities in any jurisdictions and, if filed, may never be approved in any jurisdictions or, if approved, could be severely limited by negative and restrictive labeling to the extent that commercial forecasts for CYT-1010 may never be realized.

September 8, 2022

Former Commander of the US Army Medical Command and the Former Acting Surgeon General of the Army, the first woman, non-physician to have this role in any of the military services, General Pollock was the 22nd Chief of the Army Nurse Corps. A life-long learner, she is dedicated to patient treatment and an advocate for safer & non-addictive pain management such as CYT-1010, an alternative to classical opioids. CYT-1010 is entering Phase 2 Clinical Trials

Darien, Conn., September 8, 2022 – Cytogel Pharma, a clinical stage biopharmaceutical company developing first-in-class drug candidates, dedicated to safer pain management, announced Retired Major General Gale S. Pollock, CRNA, FACHE, FAAN, has joined the firm’s Advisory Board. General Pollock was the Former Commander of the US Army Medical Command, the 22nd Chief of the Army Nurse Corps and the Former Acting Surgeon General of the Army, the first woman, non-physician to have this role in any of the military services.

CYT-1010 is an endomorphin compound that targets the right receptors of the central nervous system to block pain – with minimal adverse effects: In a Phase 1 clinical study, CYT-1010 demonstrated safety and significant analgesic activity. In preclinical studies, at therapeutic doses, it has been shown to provide:

· Safe and effective pain relief

· Impressive anti-inflammatory effects

· Little to no addiction potential

· No respiratory depression

Backed by scientific evidence that elucidates its novel mechanism of action, this groundbreaking approach is differentiating itself from that of the existing opioids and presenting an attractive alternative treatment for people in pain.

"We are delighted that General Gale Pollock, an esteemed trailblazer, is joining us as a strategic advisor, sharing her deep understanding of patient care and safe recovery,” said C. Dean Maglaris, CEO of Cytogel. "As the Former Commander of the US Army Medical Command and the Former Acting Surgeon General of the Army, the first woman, non-physician to have this role in any of the military services, General Pollock is an effective leader bringing about change and awareness in patient care and treatment. Her insight will help the momentum of our mutual mission of providing a safer, non-addictive option for pain management. The General joins us at this critical time as we take CYT-1010 into Phase 2 Clinical Development, which will bring us that much closer to realizing a safer treatment for patients in pain.”

A continual learner, General Pollock became a certified nurse anesthetist soon after her graduation from the University of Maryland. She has a Master’s degree in Business, a Master’s degree in Healthcare Administration and a Master’s degree in National Security and Strategy. She received an honorary doctorate from the University of Maryland.

While in the Army, she was challenged by Senator Daniel Inouye to address the needs of the “blinded troopers” her passion became serving the vision impaired community, safely. In 2008, she established the Louis J. Fox Center for Vision Restoration and was an associate professor at the University of Pittsburgh Schools of Medicine and Nursing. In 2011, General Pollock became a Harvard University Fellow in their “Advanced Leadership Initiative” program. She is a Fellow in the American College of Healthcare Executives, the American Academy of Nursing and certified as a Board Director by the National Board of Corporate Directors.

“Across the country and around the world, we understand the tragic increases in opioid fatalities, and as we strive to help patients, we strive to find safer solutions for pain treatment. With Cytogel’s innovative CYT-1010, an alternative to classical opioid treatment, we have an opportunity to make a substantial, life-saving impact at this critical time,” explained General Pollock. “I’m proud to work with a company that is working hard to create a new treatment, a new solution to pain treatment, avoiding the path to addiction for many.”

In addition to General Pollock, luminaries across medical, scientific and advocacy communities, have recently joined Cytogel’s advisory board, including: Patrick J. Kennedy, former U.S. Congressman, and founder of the national mental health nonprofit, The Kennedy Forum; A. Thomas McLellan, PhD., Emeritus Professor, Univ. of Pennsylvania College of Medicine, former Deputy Director, White House Office on National Drug Control Policy; and Paul Mango, Former Deputy Chief of Staff at the U.S. Department of Health and Human Services and Previous Senior Partner leading McKinsey’s Health Care Practice. Each leader is helping to advocate for safer & non-addictive pain management as CYT-1010, an alternative to classical opioids, is entering Phase 2 Clinical Trials.

Furthermore, the U.S. Trademark Certificate of Registration has been issued for Cytogel’s groundbreaking investigational stage pain medicine, CYT-1010®. Cytogel also has a solid portfolio of issued patents and patent applications claiming multiple compositions and uses of the primary molecular structure, salt forms, novel formulations, related species and new molecules.

About Cytogel Pharma:

Cytogel Pharma is a clinical stage biopharmaceutical company focused on developing promising early-stage, novel products from the endomorphin family of molecules for the treatment of moderate to severe pain, that could avoid the serious side effects of existing opioids and other analgesics.

The Company has identified and protected a number of product candidates that hold promise for success in this arena. Its lead product candidate is CYT-1010, an endomorphin 1 analog, an atypical analgesic with a demonstrated novel mechanism of action that in pre-clinical studies and one early clinical study, has shown fewer of the serious side effects of the classical opioids. This groundbreaking approach is backed by scientific evidence that differentiates it from the existing opioids and presents an attractive alternative treatment for people in pain. It is currently being developed for use in treating post-operative pain, by IV administration.

Disclosure Notice:
CYT-1010 is an investigational new drug and has not been approved by the FDA or any regulatory body for use in humans or animals. This release contains forward-looking information about CYT-1010 and a potential new indication for the treatment of patients with moderate to severe post-operative pain via IV administration. Any potential benefits that may be implied by these statements involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the possibility of unfavorable clinical trial results, unfavorable additional analyses of existing data; uncertainties regarding the commercial success of CYT-1010; the risk that regulatory authorities may not share our views on the safety and/or effectiveness of this product candidate and may require additional data or may deny approval altogether; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any new drug applications for CYT-1010 may be filed with regulatory authorities in any jurisdictions; whether and when regulatory authorities in any jurisdictions may approve any such applications that may be filed or pending for CYT-1010, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of CYT-1010.

July 12, 2022

Veterans’ Supporter, Former Deputy Chief of Staff at the U.S. Department of Health and Human Services and Previous Senior Partner leading McKinsey’s Health Care Practice, Paul Mango, advocates for safer & non-addictive pain management as CYT-1010, an alternative to classical opioids, is entering Phase 2 Clinical Trials

Darien, Conn., July 12, 2022 – Cytogel Pharma, a clinical stage biopharmaceutical company developing first-in-class drug candidates, dedicated to safer pain management, announced Paul Mango, Veteran Supporter and Former Deputy Chief of Staff at the U.S. Department of Health and Human Services, has joined the firm’s Advisory Board, which is populated with other renowned voices from the medical, scientific and advocacy community.

CYT-1010 is an endomorphin compound that targets the right receptors of the central nervous system to block pain – with minimal adverse effects: In a Phase 1 clinical study, CYT-1010 demonstrated safety and significant analgesic activity. In preclinical studies, at therapeutic doses, it has been shown to provide:

· Safe and effective pain relief

· Impressive anti-inflammatory effects

· Little to no addiction potential

· No respiratory depression

Backed by scientific evidence that elucidates its novel mechanism of action, this groundbreaking approach is differentiating itself from that of the existing opioids and presenting an attractive alternative treatment for people in pain.

"We are grateful that Paul Mango is joining us as a strategic advisor, sharing his deep experience for addressing urgent healthcare needs, including the crisis of opioid addiction and the catastrophic loss of life," said C. Dean Maglaris, CEO of Cytogel. "As the Former Deputy Chief of Staff at the U.S. Department of Health and Human Services and previous Senior Partner leading McKinsey’s Global Health Care Practice, Paul has proven to be effective in bringing forward important life-saving changes over very tight timeframes. This will help propel our mutual mission of providing a safer, non-addictive option for pain management. Paul, a positive voice for Veterans, joins us at this critical time as we take CYT-1010 into Phase 2 Clinical Development, which will bring us that much closer to realizing a safer treatment for patients in pain.”

Mr. Mango spent most of his career at McKinsey & Company, where he served healthcare clients as a Partner and Senior Partner. During Mr. Mango's tenure as a Partner, he led McKinsey's U.S. Health Care Practice and then the Global Health Care Practice. He was also the Head of McKinsey’s U.S. Center for Health Reform from 2013-2017.

After leaving McKinsey, Mr. Mango served as the Chief of Staff at the Center for Medicare and Medicaid Services (CMS) in 2018. A year later, he was appointed to the role of Deputy Chief of Staff for Policy for the Department of Health and Human Services, serving directly with Secretary Alex Azar from 2019 until January 2021. In this role, he was responsible for overseeing the introduction of industry-changing regulations involving transparency and interoperability. At the request of the White House during the COVID pandemic, Mr. Mango led an effort to rebuild the Strategic National Stockpile and played a central role in helping to deliver vaccines in record time through Project Operation Warp Speed.

Prior to his business career, Mr. Mango served in the United States Army where he was a Field Artillery Officer with the 2/321 FA, 82nd Airborne Division in Fort Bragg, NC. During his time in the service, he successfully completed training at the U.S. Army Ranger School, U.S. Army Airborne School, and U.S. Army Jumpmaster School. Mr. Mango is a graduate of the United States Military Academy at West Point where he was a Distinguished Cadet and where he earned a BS in General Engineering. He also holds an MBA from Harvard University, graduating as a Baker Scholar.

Mr. Mango is active in funding veterans’ causes over many years including the production of the documentary “Journey to Normal: Women of War Come Home”. He serves on the Board of HM3 Partners Independence Fund, a charitable gift foundation helping veterans, first responders, and youth. He lives in Jackson Hole, WY with his wife.

“We’ve seen tragic increases in opioid fatalities over the past two years and we recognize the need is real and the urgency is now. With Cytogel’s innovative, alternative to classical opioid treatment, we’re creating life-saving optionality for patients in hospitals and on the battlefield,” said Mr. Mango. “It’s a privilege to work with a company that is striving to break a common route to addiction and create a new treatment, a new solution to pain treatment.”

In addition to Mr. Mango, Cytogel recently announced that Patrick J. Kennedy, former U.S. Congressman, and founder of the national mental health nonprofit, The Kennedy Forum, has joined the firm’s Advisory Board. Christopher Gharibo, MD, a leading clinical and scientific practitioner, has also joined Cytogel’s Scientific Advisory Board. Dr. Gharibo is a Professor with the Departments of Anesthesiology, Peri-Operative Care & Pain Medicine as well as Orthopedics at New York University School of Medicine and serves as the Medical Director of Pain Medicine at NYU Langone Hospitals Center.

The U.S. Trademark Certificate of Registration has been issued for Cytogel’s groundbreaking investigational stage pain medicine, CYT-1010®. Cytogel also has a solid portfolio of issued patents and patent applications claiming multiple compositions and uses of the primary molecular structure, salt forms, novel formulations, related species and new molecules. A Composition of Matter patent is in effect until 2038.

About Cytogel Pharma:

Cytogel Pharma is a clinical stage biopharmaceutical company focused on developing promising early-stage, novel products from the endomorphin family of molecules for the treatment of moderate to severe pain, that could avoid the serious side effects of existing opioids and other analgesics.

The Company has identified and protected a number of product candidates that hold promise for success in this arena. Its lead product candidate is CYT-1010, an endomorphin 1 analog, an atypical analgesic with a demonstrated novel mechanism of action that in pre-clinical studies and one early clinical study, has shown fewer of the serious side effects of the classical opioids. This groundbreaking approach is backed by scientific evidence that differentiates it from the existing opioids and presents an attractive alternative treatment for people in pain. It is currently being developed for use in treating post-operative pain, by IV administration.

Disclosure Notice:
CYT-1010 is an investigational new drug and has not been approved by the FDA or any regulatory body for use in humans or animals. This release contains forward-looking information about CYT-1010 and a potential new indication for the treatment of patients with moderate to severe post-operative pain via IV administration. Any potential benefits that may be implied by these statements involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the possibility of unfavorable clinical trial results, unfavorable additional analyses of existing data; uncertainties regarding the commercial success of CYT-1010; the risk that regulatory authorities may not share our views on the safety and/or effectiveness of this product candidate and may require additional data or may deny approval altogether; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any new drug applications for CYT-1010 may be filed with regulatory authorities in any jurisdictions; whether and when regulatory authorities in any jurisdictions may approve any such applications that may be filed or pending for CYT-1010, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of CYT-1010.

October 15, 2021

Leading advocate, former Congressman Kennedy, champions safer and non-addictive pain management as CYT-1010®, an alternative to classical opioids, is entering Phase 2 Clinical Trials.

Darien, Conn. October 14, 2021—Cytogel Pharma, a clinical stage biopharmaceutical company developing first-in-class drug candidates, dedicated to safer pain management, announced Patrick J. Kennedy, former U.S. Congressman, and founder of the national mental health nonprofit, The Kennedy Forum, has joined the firm’s Advisory Board, which is populated with other renowned voices from the medical, scientific and advocacy community.

CYT-1010 is an endomorphin compound that targets the right receptors of the central nervous system to block pain – with minimal adverse effects: In a Phase 1 clinical study, CYT-1010 demonstrated safety and significant analgesic activity. In preclinical studies, at therapeutic doses, it has been shown to provide:

• Safe and effective pain relief

• Impressive anti-inflammatory effects

• Little to no addiction potential

• No respiratory depression

This groundbreaking approach is backed by scientific evidence that elucidates its novel mechanism of action, differentiating it from that of the existing opioids and presenting an attractive alternative treatment for people in pain.

"We are so pleased that Congressman Kennedy is joining us as a strategic advisor," said C. Dean Maglaris, CEO of Cytogel. "The Former Congressman’s years of distinguished advocacy have given him an impactful voice to help drive forward our mutual mission of providing a safer, non-addictive option for pain management. Patrick joins us at this critical time as we take CYT-1010 into Phase 2 Clinical Development, which will take us that much closer to realizing a safer treatment for patients in pain.”

During his 16 years in the U.S. House of Representatives, Kennedy co-authored the landmark Mental Health Parity and Addiction Equity Act (Federal Parity Law), which requires insurers to cover treatment for mental health and substance use disorders no more restrictively than treatment for illnesses of the body, such as diabetes and cancer.

“With its alternative to classical opioid treatment, Cytogel is on the cusp of a major medical breakthrough—one that will quite literally save lives,” said Kennedy. “We need all hands on deck when it comes to battling the public health crisis of addiction. I’m proud to work with a company that is hyper-focused on changing the status quo.”

As founder of The Kennedy Forum, former Congressman Kennedy unites advocates, business leaders, and government agencies to advance evidence-based practices and policies in mental health and addiction. In 2017, he was appointed to the President's Commission on Combating Drug Addiction and the Opioid Crisis. He currently serves as co-chair of the Action Alliance's Mental Health & Suicide Prevention National Response to COVID-19, and co-chair of the Bipartisan Policy Center's Behavioral Health Integration Task Force.

In addition to Kennedy, Cytogel recently announce that Christopher Gharibo, MD, a leading clinical and scientific practitioner, has also joined Cytogel’s Scientific Advisory Board. Dr. Gharibo is a Professor with the Departments of Anesthesiology, Peri-Operative Care & Pain Medicine as well as Orthopedics at New York University School of Medicine and serves as the Medical Director of Pain Medicine at NYU Langone Hospitals Center.

The U.S. Trademark Certificate of Registration has been issued for Cytogel’s groundbreaking investigational stage pain medicine, CYT-1010®. Cytogel also has a solid portfolio of issued patents and patent applications claiming multiple compositions and uses of the primary molecular structure, salt forms, novel formulations, related species and new molecules. The Composition of Matter patent is in effect until 2038.

About Cytogel Pharma:

Cytogel Pharma is a clinical stage biopharmaceutical company focused on developing promising early-stage, novel products from the endomorphin family of molecules for the treatment of moderate to severe pain, that could avoid the serious side effects of existing opioids and other analgesics.

The Company has identified and protected a number of product candidates that hold promise for success in this arena. Its lead product candidate is CYT-1010, an endomorphin 1 analog, an atypical analgesic with a demonstrated novel mechanism of action that in pre-clinical studies and one early clinical study, has shown fewer of the serious side effects of the classical opioids. This groundbreaking approach is backed by scientific evidence that differentiates it from the existing opioids and presents an attractive alternative treatment for people in pain. It is currently being developed for use in treating post-operative pain, by IV administration.

Disclosure Notice:
CYT-1010 is an investigational new drug and has not been approved by the FDA or any regulatory body for use in humans or animals. This release contains forward-looking information about CYT-1010 and a potential new indication for the treatment of patients with moderate to severe post-operative pain via IV administration. Any potential benefits that may be implied by these statements involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the possibility of unfavorable clinical trial results, unfavorable additional analyses of existing data; uncertainties regarding the commercial success of CYT-1010; the risk that regulatory authorities may not share our views on the safety and/or effectiveness of this product candidate and may require additional data or may deny approval altogether; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any new drug applications for CYT-1010 may be filed with regulatory authorities in any jurisdictions; whether and when regulatory authorities in any jurisdictions may approve any such applications that may be filed or pending for CYT-1010, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of CYT-1010.

September 2, 2021

_Cytogel Pharma announced the U.S. Trademark Certificate of Registration has been issued for its groundbreaking investigational stage pain medicine, CYT-1010^®

DARIEN, CT, September 2, 2021-- Cytogel Pharma, a clinical stage biopharmaceutical company developing first-in-class drug candidates, dedicated to safer pain management, announced the U.S. Trademark Certificate of Registration has been issued for its groundbreaking investigational stage pain medicine, CYT-1010^®. U.S. Registration Certificate is issued by the U.S. Patent & Trademark Office in August 2021 for CYT-1010 in International Class 005 for ten years with the option to renew.

CYT-1010 is an endomorphin therapy that targets the right receptors of the central nervous system to block pain – with minimal adverse implications: In a Phase 1 clinical study, CYT-1010 demonstrated safety and significant analgesic activity. In preclinical studies, at therapeutic doses, it has been shown to provide:

• Safe and effective pain relief

• Impressive anti-inflammatory effects

• Little to no addiction potential

• No respiratory depression

“At Cytogel, we’re pleased that the U.S. Trademark Certificate of Registration recognizes CYT-1010, as we are entering Phase 2 Clinical Trials with this important and impactful pain medicine,” commented *C. Dean Maglaris, Cytogel CEO. “This registration, the strength of our Scientific Advisory Board and our patent portfolio illustrate such positive momentum that we are excited for the future and the potential impact this can have in treating pain, safely and effectively.”

Cytogel recently announced a key addition to its Scientific Advisory Board of Dr. Christopher Gharibo, Professor, Department of Anesthesiology & Pain Medicine as well as Orthopedics at New York University School of Medicine, and Medical Director of Pain Medicine of NYU Langone Hospitals Center.

The Company has a solid portfolio of issued patents and patent applications claiming multiple compositions and uses of the primary molecular structure, salt forms, novel formulations, related species and new molecules. The Composition of Matter patent is in effect until 2038.

About Cytogel Pharma:
Cytogel Pharma is a clinical stage biopharmaceutical company focused on developing promising early-stage, novel products for the treatment of moderate to severe pain, that could avoid the serious side effects of existing opioids and other analgesics. The Company has identified and protected a number of product candidates that hold promise for success in this arena. Its lead product candidate is CYT-1010, an endomorphin 1 analog, an atypical analgesic with a demonstrated novel mechanism of action that in pre-clinical studies and one early clinical study, has shown fewer of the serious side effects of the classical opioids. It is currently being developed for use in treating post-operative pain, by IV administration.

Cytogel is a clinical stage biopharmaceutical company developing first-in-class drug candidates, from the novel endomorphin family of molecules, that target key pain pathways and alleviate pain. This groundbreaking approach is backed by scientific evidence that elucidates its novel mechanism of action, differentiating it from that of the existing opioids and presenting an attractive alternative treatment for people in pain.

Disclosure Notice:
CYT-1010 is an investigational new drug and has not been approved by the FDA or any regulatory body for use in humans or animals. This release contains forward-looking information about CYT-1010 and a potential new indication for the treatment of patients with moderate to severe post-operative pain via IV administration. Any potential benefits that may be implied by these statements involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the possibility of unfavorable clinical trial results, unfavorable additional analyses of existing data; uncertainties regarding the commercial success of CYT-1010; the risk that regulatory authorities may not share our views on the safety and/or effectiveness of a product candidate and may require additional data or may deny approval altogether; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any new drug applications for CYT-1010 may be filed with regulatory authorities in any jurisdictions; whether and when regulatory authorities in any jurisdictions may approve any such applications that may be filed or pending for CYT-1010, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of CYT-1010.

June 3, 2021

Cytogel Pharma Announces that Christopher Gharibo, MD has joined its Scientific Advisory Board

Dr. Christopher Gharibo, a clinical and scientific leader in pain management, has joined Cytogel's Scientific Advisory Board as the firm prepares to initiate Phase 2 clinical studies for its lead compound, CYT-1010, the first clinical candidate from a new family of endogenous analgesics with a novel mechanism of action.

DARIEN, Conn., June 3, 2021 – Cytogel Pharma, a clinical stage biopharmaceutical company developing first-in-class drug candidates for the safer treatment of moderate to severe pain, has announced that Christopher Gharibo, MD, a leading clinical and scientific practitioner, has joined its Scientific Advisory Board. Dr. Gharibo’s extensive clinical and academic credentials in anesthesiology will further enhance the breadth of experience of the Scientific Advisory Board. “I am excited to join the Cytogel Scientific Advisory Board at this time as the Company is entering Phase 2 development for CYT-1010 which, I believe, has the potential to transform the post-surgical management of moderate to severe pain” said Dr. Gharibo.

C. Dean Maglaris, Cytogel CEO commented, "We’re incredibly pleased that Dr. Gharibo joins our impactful Scientific Advisory Board, as he is a leading voice in pain management, and he further strengthens our program and mission. His involvement, at this critical point in the development of CYT-1010, will enhance our ability to make a real difference in the area of post-operative pain."

Dr. Gharibo is a Professor with the Departments of Anesthesiology, Peri-Operative Care & Pain Medicine as well as Orthopedics at New York University School of Medicine and serves as the Medical Director of Pain Medicine at NYU Langone Hospitals Center. In 2019 Dr. Gharibo received the Outstanding Pain Physician Award during the New York and New Jersey Society of Interventional Pain Physicians Annual Meeting. He is the Chairman of the Pain Steering Committee for NYU Langone Health, New York and has been instrumental in developing and overseeing the pain medicine department for NYU.

Cytogel’s lead compound, CYT-1010, is the first in a new class of anti-hyperalgesic endomorphins, with a novel mechanism of action <https://cytogelpharma.com/novel-mechanism-of-action/>, to enter human clinical development. CYT-1010, a molecule that has proven to be more potent than morphine, exhibits a clinical profile of effective pain relief with decreased neurological sensitization and improved side effect profile, without respiratory depression at therapeutic doses, while exhibiting less euphoria and potential for addiction. In preclinical studies and a Phase 1 study, CYT-1010 has been shown to provide:

• Safe and effective pain relief
• Impressive anti-inflammatory effects
• No respiratory depression
• Little to no addiction potential

"Cytogel strives to address the challenges of post-operative pain treatment that have been in place for decades, namely providing effective analgesia, and decreased neurogenic inflammation without respiratory depression and addiction. This is our objective for CYT-1010 and, if successful, it has the potential to greatly improve the safe treatment of post-operative pain, based on its novel mechanism of action,” explained Maglaris.

The Company has a solid portfolio of issued patents and patents pending that extend to 2038 and claiming multiple compositions and uses of the primary molecular structure, salt forms, novel formulations, related species and new molecules.

About Cytogel Pharma:

Cytogel Pharma is a clinical stage biopharmaceutical company focused on developing promising early-stage, novel products for the treatment of moderate to severe pain, that could avoid the serious side effects of existing opioids and other analgesics. The Company has identified and protected a number of product candidates that hold promise for success in this arena. Its lead product candidate is CYT-1010, an endomorphin 1 analog, an atypical analgesic with a demonstrated novel mechanism of action that in pre-clinical studies and one early clinical study, has shown fewer of the serious side effects of the classical opioids. It is currently being developed for use in treating post-operative pain, by IV administration.

Cytogel is a clinical stage biopharmaceutical company developing first-in-class drug candidates, from the novel endomorphin family of molecules, that target key pain pathways and alleviate pain. This groundbreaking approach is backed by scientific evidence that elucidates its novel mechanism of action, differentiating it from that of the existing opioids and presenting an attractive alternative treatment for people in pain.

Disclosure Notice:
CYT-1010 is an investigational new drug and has not been approved by the FDA or any regulatory body for use in humans or animals. This release contains forward-looking information about CYT-1010 and a potential new indication for the treatment of patients with moderate to severe post-operative pain via IV administration. Any potential benefits that may be implied by these statements involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the possibility of unfavorable clinical trial results, unfavorable additional analyses of existing data;

uncertainties regarding the commercial success of CYT-1010; the risk that regulatory authorities may not share our views on the safety and/or effectiveness of a product candidate and may require additional data or may deny approval altogether; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any new drug applications for CYT-1010 may be filed with regulatory authorities in any jurisdictions; whether and when regulatory authorities in any jurisdictions may approve any such applications that may be filed or pending for CYT-1010, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of CYT-1010.

October 28, 2020

Cytogel Announces Addition of A. Thomas McLellan, PhD to its Scientific Advisory Board

A. Thomas McLellan, PhD joins Cytogel's Scientific Advisory Board as firm enters Phase 2 for lead compound in pain treatment

We are very pleased that Dr. McLellan is joining Cytogel at this pivotal time in our pursuit of a transformational pain solution that will avoid addiction and respiratory depression.”

— Dean Maglaris, CEO and Chairman of Cytogel 

DARIEN, CONN., October 28, 2020 /EINPresswire.com/ -- Cytogel Pharma, a clinical stage biopharmaceutical company developing first-in-class drug candidates and dedicated to safer pain management, announced today that A. Thomas McLellan, PhD has joined its Scientific Advisory Board. The Company’s mission is to bring to market safer, effective pain treatments, which would transform the experience for patients and healthcare workers alike.

Dr. McLellan is Emeritus Professor of Psychiatry at the University of Pennsylvania and brings a wealth of experience and expertise on addiction prevention and treatment. He is co-founder and Chief Executive Officer of the Treatment Research Institute (TRI), a not-for-profit research and development institute in Philadelphia, and has worldwide recognition for his more than 40 years of research. He has published over 525 articles and chapters on addiction research and successfully completed over 150 NIH research grants. Dr. McLellan is the recipient of several distinguished awards including the Life Achievement Awards of the American and British Societies of Addiction Medicine; the Robert Wood Johnson Foundation Innovator Award; and awards for Distinguished Contribution to Addiction Medicine from the Swedish (2002) and Italian (2002) Medical Associations.

Cytogel’s lead compound, CYT-1010, is the first in a new class of drugs, the endomorphins, with a novel mechanism of action, to enter human clinical development. CYT-1010 targets the right receptors of the central nervous system, has proven to be more potent than morphine and has demonstrated an improved side effect profile of less potential for addiction and little or no respiratory depression at therapeutic doses. In preclinical studies and a Phase 1 study, CYT-1010 has been shown to provide:

- Safe and effective pain relief
- Impressive anti-inflammatory effects
- Little to no addiction potential
- No respiratory depression

“We are very pleased that Dr. McLellan is joining us at this pivotal time in our pursuit of a transformational pain solution that will avoid addiction and respiratory depression,” Dean Maglaris, CEO and Chairman of Cytogel commented. “Dr. McLellan’s reputation as a highly renowned researcher and key opinion leader on substance abuse and drug addiction is very well known. He brings a passion for breaking the cycle of pain and addiction from many of the current pain treatments and will further strengthen our development program for CYT-1010.”

Dr. McLellan joins Lynn Webster, MD, pain physician and researcher, VP Scientific Affairs with PRA Health Services and William Schmidt, PhD, pain researcher and President of NorthStar Consulting along with Cytogel’s full Scientific Advisory Team of experts.

“It’s my privilege to work alongside Lynn and Bill and the full Cytogel Scientific Advisory Board,” Dr. McLellan stated. “I am enthusiastic about CYT-1010, as a member of the endomorphin family, and believe it represents the best option for solving the pain and addiction challenge of the opioids. I look forward to participating in its ground-breaking development.”

About Cytogel:
Cytogel is a clinical stage biopharmaceutical company developing first-in-class drug candidates, from the novel endomorphin family of molecules, that target key pain pathways and alleviate pain. This groundbreaking approach is backed by scientific evidence that elucidates its novel mechanism of action, differentiating it from that of the existing opioids and presenting an attractive alternative treatment for people in pain.

For additional information, visit: CytogelPharma.com

Disclosure Notice
CYT-1010 is an investigational new drug and has not been approved by the FDA or any regulatory body for use in humans or animals. This release contains forward-looking information about CYT-1010 and a potential new indication for the treatment of patients with moderate to severe post-operative pain via IV administration. Any potential benefits that may be implied by these statements involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the possibility of unfavorable clinical trial results, unfavorable additional analyses of existing data; uncertainties regarding the commercial success of CYT-1010; the risk that regulatory authorities may not share our views on the safety and/or effectiveness of a product candidate and may require additional data or may deny approval altogether; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any new drug applications for CYT-1010 may be filed with regulatory authorities in any jurisdictions; whether and when regulatory authorities in any jurisdictions may approve any such applications that may be filed or pending for CYT-1010, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of CYT-1010.

# # #

September 24, 2019

William K Schmidt, PhD presented “The Challenge of Addiction and Respiratory Depression in the Treatment of Pain: A Prototypical Endomorphin as a New Approach for Moderate-Severe Pain Relief”

William K Schmidt, PhD presented “The Challenge of Addiction and Respiratory Depression in the Treatment of Pain: A Prototypical Endomorphin as a New Approach for Moderate-Severe Pain Relief” during the 13th Annual Pain Therapeutics Summit was hosted in Washington DC on September 23-24, 2019. The conference focused on: Identifying and Advancing Novel Pain Drugs Through Clinical Development and Commercialization.

June 5, 2019

Cytogel Pharma announces the publication of “Dilemma of Addiction and Respiratory Depression in the Treatment of Pain: A Prototypical Endomorphin as a New Approach” – Pain Medicine Journal

Authors:

• Lynn Webster, M.D., Past President American Academy of
• Pain Medicine, VP Scientific Affairs, PRA Health Sciences
• William K. Schmidt, Ph.D.,  noted authority in clinical pain  research

This scientific review article summarizes the pre-clinical and clinical development data on CYT-1010, in light of available scientific evidence for existing analgesics and those in development.  It is stated that “Conventional opioids, while effective for the treatment of moderate to severe pain, are associated with safety concerns (addiction, respiratory depression, and overdose deaths) that have been magnified by the current opioid epidemic and crisis.”

”In preclinical studies and in a single dose phase 1 study, CYT-1010 has been shown to have strong antinociceptive [analgesic] properties comparable to morphine, but with less potential for respiratory depression or reward.”

“Pain Medicine” is an official journal of the American Academy of Pain Medicine

February 20, 2019

Cytogel Pharma, LLC. announces the election of Steven G. Chrust to its Board of Managers.
- Darien, CT.

Dean Maglaris, CEO and Chairman stated, "I am pleased to announce the unanimous election by the Company's Board of Managers of Steven Chrust to its Board. Steven has been closely involved with Cytogel from its early days and has been an invaluable Board observer for many years. Steven brings extensive experience in business, management and finance to the Board. He will be taking the seat vacated by the recent and sad passing of E. Bulkeley Griswold who had been on the Board since its inception.

Steven is founder and Senior Managing Partner of Centripetal Capital Partners (www.centricap.com) a private equity investment firm founded in 2004. He is also Founder and President of SGC Advisory Services, Inc., since 1991. Mr. Chrust serves on several boards, including as Chairman of APJeT, Inc. and IMCS. He is a member of the Association for Investment Management and Research and the New York Society of Securities Analysts. He has lectured at the Harvard Business School and testified before Congress concerning the break-up of AT&T, and before state public utility commissions on various regulatory matters. In 1994, he co-founded WinStar Communications, Inc., a facilities based local telecommunications provider utilizing fixed wireless technology and served as its Vice Chairman until the end of 1998. Mr. Chrust also served as Chairman of Worlds.com between 1999-2001. He began his career in 1970, at Sanford C. Bernstein & Co., Inc., a financial institution handling more than $400 billion in client assets, currently known as AllianceBernstein. While at Bernstein, he was Director of Technology Research and ranked in the top tier of telecommunications analysts for more than a decade by Institutional Investor and ranked the #1 analyst in the sector for five consecutive years in their all-star ranking. Mr. Chrust is a graduate of Bernard M. Baruch College of the City University of New York and attended its business graduate school.

About Cytogel Pharma

Cytogel Pharma, LLC. is a biopharmaceutical development company based in Darien, Connecticut, focused on developing promising early-stage programs that offer significant potential both as platform technologies and high value product candidates for the treatment of pain. Cytogel will develop products to the point of demonstrated value, proof of concept stage, and then license these products to other larger companies for the full scientific and clinical development and subsequent commercialization. To learn more about Cytogel, please visit our website at www.cytogelpharma.com

Feb 05, 2019

Cytogel Pharma Announces Receipt of FDA Authorization to Commence Phase 2 Development for its Atypical Opioid, CYT-1010

- Company announces initial path forward to phase 2 clinical studies on CYT-1010

DARIEN, Conn., Feb. 5, 2019 /PRNewswire/ -- Cytogel Pharma, LLC. today announced receipt of the official response from the U.S. Food and Drug Administration (FDA) regarding the Company's amendment to the Complete Response Letter (CRL) for the CYT-1010 Investigational New Drug (IND) application.

FDA has agreed that the Company may proceed with its phase 1a/2a study protocol titled, A Randomized Double-Blind, Single-Dose, Placebo-Controlled Pharmacokinetic and Proof-of-Concept Study to Evaluate the Safety of CYT-1010 in Healthy Volunteers and the Analgesic Efficacy and Tolerability of CYT-1010 vs. Morphine in Subjects with Moderate to Severe Pain after Third Molar Extraction.

The FDA issued authorization that allows this study to proceed. This will be an important proof of concept study and dose ranging study to demonstrate the effectiveness and safety of CYT-1010 in both volunteers and patients with significant pain. The FDA indicated that, upon completion of the above study, the Company should submit data to the Division for advancing to higher doses of CYT-1010, hence a partial clinical hold (PCH) in development will be in effect. The Division will review these data before lifting the PCH and allowing higher doses of CYT-1010.

"We are pleased with the productive dialogue with the FDA and their decision to authorize the initiation of phase 2 development of CYT-1010 by approving this first study protocol, opening a pathway to full clinical development of CYT-1010. This is an important step forward for the Company. We believe the design of the phase 1a/2a study will allow for demonstration of safety and efficacy of this novel candidate in the treatment of post-operative pain," said C. Dean Maglaris, President and Chief Executive Officer. "Our mission is to address the needs of post-operative pain treatment, by providing effective analgesia that would not be as limited by the serious side effects of the classical opioids, namely respiratory depression and addiction. This is our objective for CYT-1010, based on its mechanism of action that is novel among opioids."

The Company also announced that it is currently completing a bridge financing, which will shortly lead to a follow-on round of financing to fund its development programs. If completed, management expects these financings should be sufficient to fund operating expenses and project expenditure requirements into first quarter 2022.

About Cytogel Pharma

Cytogel Pharma is a biopharmaceutical company focused on developing promising early-stage, novel products for the treatment of moderate to severe pain, that could avoid the classical serious side effects of existing opioids and other analgesics. The Company has identified and protected a number of product candidates that hold promise for success in this arena. Its lead product candidate is CYT-1010, an endomorphin 1 analog, an atypical opioid with a demonstrated novel mechanism of action that in pre-clinical studies and one early clinical study, has shown fewer of the serious side effects of the classical opioids. It is currently being developed for use in treating post-operative pain, by IV administration. The Company's portfolio also includes broadly useful polymer and hydrogel drug delivery technologies, which can be useful in enhancing the pharmacokinetics of other drugs.

Disclosure Notice

CYT-1010 is an investigational new drug and has not been approved by the FDA or any regulatory body for use in humans or animals. This release contains forward-looking information about CYT-1010 and a potential new indication for the treatment of patients with moderate to severe post-operative pain via IV administration. Any potential benefits that may be implied by these statements involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the possibility of unfavorable clinical trial results, unfavorable additional analyses of existing data; uncertainties regarding the commercial success of CYT-1010; the risk that regulatory authorities may not share our views on the safety and/or effectiveness of a product candidate and may require additional data or may deny approval altogether; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any new drug applications for CYT-1010 may be filed with regulatory authorities in any jurisdictions; whether and when regulatory authorities in any jurisdictions may approve any such applications that may be filed or pending for CYT-1010, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of CYT-1010.