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June 1, 2014 - Ogenx Receives $200,000 in FDA Grants For Canine Cancer Trials

June 1, 2014 - OgenXTM OgenX Therapeutics announced today that the FDA's Center for Veterinary Medicine (CVM) Office of Minor Uses / Minor Species (OMUMS) and the FDA Office of Acquisitions & Grants Services has approved two separate grant applications totaling $200,000 for the treatment of Canine Lymphoma and Canine Mast Cell Tumors with the new Ogenx Drug RC-2 Beta. Dr. Richard Davis, OgenX's Chief Executive Officer, said that "this is the second batch of grants approved by FDA, in addition to two other grants totaling $150,000 and represents a significant endorsement of the Company's clinical development program, and a major step forward towards our commercialization objective utilizing the MUMS NADA Conditional Approval pathway for these two indications."

Dr. Davis went on to say that "the criteria for receiving the competitive FDA grants are very challenging. For example, only new animal drug products that have been "Designated" by the CVM OMUMS are eligible for grants. The FDA OMUMS Designation Status provisions were designed and modeled based on the "Orphan Drug Act" for humans, which encourages pharmaceutical sponsors to develop drugs for rare diseases in people, by providing incentives for approval. In addition, the study protocols in the grant applications must be under an active Investigational New Animal Drug (INAD) file; the OgenX Product Development Plan must have been approved by the FDA, and the protocols must have been reviewed and accepted by the FDA CVM's Office of New Animal Drug Evaluation (ONADE) prior to the applicant's submission of a grant application. Each grant application has been reviewed by an independent expert panel in accordance with the review criteria identified in RFA-FD-12-003. Based on the FDA panel's review, the request for funding for each application was approved. These serial expert reviews of OgenX's clinical plans and protocols by the both the FDA as well as the Independent Review Panels demonstrate the importance and confirm the validity of the Company's RC-2 Beta Development Program for the treatment of Canine Lymphoma and Canine Mast Cell Tumors with RC-2 Beta.

Dr. Davis further mentioned that "the purpose of the Canine Lymphoma clinical trial is to determine the safety and effectiveness RC-2 Beta in client-owned canines with either newly diagnosed or first relapse intermediate to high grade Lymphoma. Currently, regardless of treatment, 99% of dogs diagnosed with lymphoma die of the disease within an average of 12 months of diagnosis. The purpose of the Canine Mast Cell Tumor clinical trial is to determine the safety and effectiveness of RC-2 Beta in client-owned canines with non-resectable Grade II and Grade III Mast Cell Tumors that have not received previous therapy except for corticosteroids. High grade Mast Cell Tumors (Grade II and III) have metastatic rates ranging from 50-90%, and once the tumors spread, the prognosis is very poor, where most dogs will die of the disease."

Both of these studies will be conducted under FDA CVM-accepted research protocols, and are intended to provide FDA CVM with sufficient evidence that RC-2 Beta demonstrates safety and has a 'reasonable expectation of effectiveness' in treating dogs with Lymphoma and Mast Cell Tumors. If the studies achieve these objectives, RC-2 Beta will be eligible for FDA Conditional Approval for both of these intended uses which comprise the largest segment of canine cancers. If RC-2 Beta obtains FDA Conditional Approval, Ogenx immediately has seven years of exclusivity and can market the drug without restriction or delay. Moreover, OgenX has up to five years to demonstrate substantial evidence of effectiveness through a larger clinical field trial to complete the Effectiveness technical section required for full NADA approval of the drug for these uses.

Both studies will be carried out in parallel by the Texas A&M University Veterinary Medical Teaching Hospital, which already has approved the studies under the Direction of Dr. Heather Wilson-Robles (Principal Investigator), a widely recognized expert in canine cancer. These studies, if successful, will represent a major step forward in the treatment of essentially untreatable cancers in dogs. Current chemotherapy treatments are costly, toxic for normal cells, and not particularly efficacious.

Dr. Richard Davis, also went on to state: "We are delighted to be among the earliest pioneers in this therapeutic area of urgent unmet medical need and are moving forward with the RC-2 Beta Clinical Development Program as quickly as possible. RC-2 Beta is a novel mitochondrial medicine and represents our lead compound in the Redoxagen Platform of therapeutic agents. Their mode of action is entirely different from traditional chemotherapeutic poisons. Based on our preliminary work in this area, we have a significant degree of confidence in the positive outcomes of these trials."

OgenX's two MUMS designations are listed on the FDA's link at:
http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/MinorUseMinorSpecies/ucm064838.htm


March 12, 2014 - Ogenx Enrolls First Dogs Into CANON-1 Veterinary Trial

March 12, 2014 - OgenXTM Therapeutics Corporation announced today announced today that its first two patients have been successfully enrolled and received their initial treatments this week in the CANON-1 (Canine Oncology) Trial at the College of Veterinary Medicine and Biological Sciences at Texas A&M University (TAMU). Assistant Professor of Oncology, Dr. Heather Wilson-Robles, heads the study as its Principal Investigator; which is evaluating OgenX's lead veterinary cancer compound, RC-2Beta, for both: a) non-resectable Grade II and Grade III Mast Cell Tumors that have not received previous therapy except for corticosteroids, and b) High grade Mast Cell Tumors (Grade II and III).

The Company's dual-arm, prospective, open label study design has been approved by the FDA's Center for Veterinary Medicine (CVM), which also awarded the Company with two MUMS designation grants to help fund the trial. Twenty-five Client-owned dogs will be recruited for enrollment at TAMU's Small Animal Clinical Sciences Teaching Hospital in College Station, TX for the study.

Dr. Wilson-Robles stated: "I am very excited to be the Lead Principal Investigator of this program. Lymphosarcoma and Mast Cell Tumors are two of the most common and deadly cancers that we see in our practice, with few treatment options beyond traditional surgery, radiotherapy and chemotherapy choices. With advancing degrees of tumor burden, prognosis is very poor, and most dogs will ultimately succumb to the disease despite our best current therapies. Should RC-2Beta prove to be safe and effective, having this additional therapeutic option will offer new hope to our patients and their owners."

OgenX's CEO, Dr. Richard Davis, stated that: "We are very pleased that RC-2Beta has reached this pivotal milestone. We are deeply grateful for the tireless efforts of the TAMU staff and for CVM's support for this Clinical Development Program. Based on our previous clinical work, we have a high degree of confidence for a positive outcome for CANON-1."

The Redoxagens are a pioneering, first of therapeutic class platform of 35 novel mitochondrial medicines. The molecular basis for their pharmacological effect lies in their unique ability to amplify therapeutic cell signaling mechanisms via targeted bursts of mitochondrial redox reactions in select loci along the electron transport chains of oxidatively stressed cells.

The CANON-1 Trial is a dual-arm study designed to determine the safety and reasonable expectation for effectiveness of RC-2Beta for certain Canine Mast Cell Tumors and Canine Lymphosarcoma indications. It is being advanced under the Company's Investigational New Animal Drug (INAD) application; and is being conducted in accordance with guidance from the FDA's Center for Veterinary Medicine (CVM) Office of Minor Uses / Minor Species (OMUMS). The Centers for Clinical Research (Chicago, IL) is providing independent monitoring for the trial.

OgenX is only the fourth company to ever obtain MUMS Designations for these two indications. The FDA OMUMS Designation Status provisions provide a fast track approval pathway for early commercialization, along with other incentives to encourage pharmaceutical sponsors to develop drugs for certain diseases of particular interest. If CANON-1 achieves its objectives, RC-2 Beta will be eligible to submit for FDA Conditional Approval for both of these disease targets which comprise the largest segment of unmet medical need in canine cancers. If RC-2Beta obtains FDA Conditional Approval, the MUMS program provides for seven years of market exclusivity whereby the drug can be immediately marketed without restriction under labeling indicating the disease targets studied. Moreover, OgenX has up to five years to complete the Effectiveness technical section, demonstrating substantial evidence of effectiveness through a larger clinical field trial as required for a full NADA submission of the drug for these uses.


December 17, 2013 - Ogenx Receives $150,000 In FDA Grants For Canine Cancer Trials

December 17, 2013 - OgenXTM Therapeutics Corporation announced today that the FDA's Center for Veterinary Medicine (CVM) Office of Minor Uses / Minor Species (OMUMS) and the FDA Office of Acquisitions & Grants Services has approved two separate $75,000 grant applications for the treatment of Canine Lymphoma and Canine Mast Cell Tumors with the new Ogenx Drug RC-2 Beta. Dr. Peter Urrea, OgenX's Chief Regulatory Officer, said that "the FDA's approval of both grants totaling $150,000 represents a significant endorsement of the Company's clinical development program, and a major step forward towards our commercialization objective utilizing the MUMS NADA Conditional Approval pathway for each indication."

Dr. Urrea went on to say that "the criteria for receiving the competitive FDA grants are very challenging. For example, only new animal drug products that have been "Designated" by the CVM OMUMS are eligible for grants. The FDA OMUMS Designation Status provisions were designed and modeled based on the "Orphan Drug Act" for humans, which encourages pharmaceutical sponsors to develop drugs for rare diseases in people, by providing incentives for approval. In addition, the study protocols in the grant applications must be under an active Investigational New Animal Drug (INAD) file; the OgenX Product Development Plan must have been approved by the FDA, and the protocols must have been reviewed and accepted by the FDA CVM's Office of New Animal Drug Evaluation (ONADE) prior to the applicant's submission of a grant application. On December 2, 2013, each grant application was independently reviewed by an independent expert panel in accordance with the review criteria identified in RFA-FD-12-003. Based on the FDA panel's review, the request for funding for each application was approved. These serial expert reviews of OgenX's clinical plans and protocols by the both the FDA as well as the Independent Review Panels demonstrate the importance and confirm the validity of the Company's RC-2 Beta Development Program for the treatment of Canine Lymphoma and Canine Mast Cell Tumors with RC-2 Beta.

Dr. Urrea further mentioned that "the purpose of the Canine Lymphoma clinical trial is to determine the safety and effectiveness RC-2 Beta in client-owned canines with either newly diagnosed or first relapse intermediate to high grade Lymphoma". Currently, regardless of treatment, 99% of dogs diagnosed with lymphoma die of the disease within an average of 12 months of diagnosis. The purpose of the Canine Mast Cell Tumor clinical trial is to determine the safety and effectiveness of RC-2 Beta in client-owned canines with non-resectable Grade II and Grade III Mast Cell Tumors that have not received previous therapy except for corticosteroids. High grade Mast Cell Tumors (Grade II and III) have metastatic rates ranging from 50-90%, and once the tumors spread, the prognosis is very poor, where most dogs will die of the disease.

Both of these studies will be conducted under FDA CVM-accepted research protocols, and are intended to provide FDA CVM with sufficient evidence that RC-2 Beta demonstrates safety and has a 'reasonable expectation of effectiveness' in treating dogs with Lymphoma and Mast Cell Tumors. If the studies achieve these objectives, RC-2 Beta will be eligible for FDA Conditional Approval for both of these intended uses which comprise the largest segment of canine cancers. If RC-2 Beta obtains FDA Conditional Approval, Ogenx immediately has seven years of exclusivity and can market the drug without restriction or delay. Moreover, OgenX has up to five years to demonstrate substantial evidence of effectiveness through a larger clinical field trial to complete the Effectiveness technical section required for full NADA approval of the drug for these uses.

Both studies will be carried out in parallel by the Texas A&M University Veterinary Medical Teaching Hospital which already has approved the studies under the Direction of Dr. Heather Wilson-Robles (Principal Investigator), a widely recognized expert in canine cancer. These studies, if successful, will represent a major step forward in the treatment of essentially untreatable cancers in dogs. Current chemotherapy treatments are costly, toxic for normal cells, and not particularly efficacious.”

OgenX's CEO, Dr. Richard Davis, stated that: "We are delighted to be among the earliest pioneers in this therapeutic area of urgent unmet medical need and are moving forward with the RC-2 Beta Clinical Development Program as quickly as possible. RC-2 Beta is a novel mitochondrial medicine and represents our lead compound in the Redoxagen Platform of therapeutic agents. Their mode of action is entirely different from traditional chemotherapeutic poisons. Based on our preliminary work in this area, we have a significant degree of confidence in the positive outcomes of these trials."

Dr. Davis continued: "RC-2 Beta clinical drug supplies are currently being manufactured by one of the leading Pharmaceutical developers in the world to commercial cGMP standards. We plan to have finished clinical study drug inventory in Q1 2014. Study start up for both the Lymphoma and Mast Cell Tumors will begin shortly thereafter, with patient enrollment plan to begin in early Q2 2014. This timeline extends our lead ahead of all other potentially competitive development programs that we are aware of; and will keep us on track for the filing of the FDA Conditional Approval later in 2014 with our target to commercialize RC-2 Beta for both Canine Lymphoma and Canine Mast Cell Tumors in early 2015."

OgenX's two MUMS designations are listed on the FDA's link at:
http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/MinorUseMinorSpecies/ucm064838.htm


August 6, 2013 - FDA Grants MUMS Designations For RC-2 Beta For Certain Canine Lymphoma And Canine Mast Cell Tumor Indications

August 6, 2013 - OgenXTM Therapeutics Corporation announced today that the FDA's Center for Veterinary Medicine (CVM) Office of Minor Uses / Minor Species (OMUMS) has granted two MUMS Designations for the Company's lead compound RC-2 Beta (Geroxane), to be used in the treatment of Canine Lymphoma and Canine Mast Cell Tumors, two of the most common cancers in dogs. The FDA has also previously granted Ogenx waivers of FDA user fees for both indications. The FDA OMUMS Designation Status provisions were designed and modeled based on the "Orphan Drug Act" for humans, which encourages pharmaceutical sponsors to develop drugs for rare diseases in people, by providing incentives for approval.

Dr. Peter Urrea, OgenX's Chief Regulatory Officer stated that "this is a highly significant critical path milestone for the RC-2 Beta Drug Development Program, and culminates the FDA's acceptance of our RC-2 Beta Product Development Plan for Conditional Approval for both canine cancer indications through the NADA submission process."

Dr. Urrea went on to say that "in terms of importance, these two Designation letters are at the top of the list of the FDA New Animal Drug Application (NADA) registration process for Conditional Approval and early commercialization of RC-2 Beta. He mentioned that the numerous benefits of these Designations are very significant for Ogenx and the patients that will be treated. For each indication we now have: 1) seven years of market exclusivity following the date of NADA Conditional Approval or full NADA approval; 2) the right to file for Conditional Approval which will allow Ogenx early marketing of RC-2 Beta for up to five years as long as we have demonstrated that there is a reasonable expectation that RC-2 Beta is effective, and that we prove that RC-2 Beta is safe in accordance with the full FDA approval standard prior to receiving conditional approval and , 3) the right to apply for and receive up to five FDA MUMS Grants which could total between $375,000 to $425,000 if we are successful in receiving all of the Grants that are currently being filed. In addition, we are working closely with our RC-2 Beta manufacturing partners (PharmaCore and Althea Technologies), to prove that RC-2 Beta is a quality-validated manufactured product made in accordance with current Good Manufacturing Practice regulations, and that the RC-2 Beta commercial product is properly labeled."

OgenX's CEO, Dr. Richard Davis, stated that: "We are delighted to be among the earliest pioneers in this therapeutic area of urgent unmet medical need. This is only the 3rd time in CVM's history that a MUMS designation has been provided for a drug for Canine Mast Cell Tumors and the 4th time for Canine Lymphoma. These MUMS Designations keep us on track for the filing for Conditional Approval to commercialize RC-2 Beta for these two common fatal illnesses in 2014."

OgenX's two MUMS designations will soon be listed on the FDA's link at: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/MinorUseMinorSpecies/ucm064838.htm


June 10, 2013 - FDA Agrees With Plan to Obtain Conditional Approval For Canine Lymphoma and Canine Mast Cell Tumor Indications

June 10, 2013 - OgenXTM Therapeutics Corporation announced that the FDA's Center for Veterinary Medicine (CVM) has agreed with the Company's Product Development Plan submission for the New Animal Drug Application (NADA) for Conditional Approval of RC-2 Beta for the treatment of two of the most common cancers in dogs: Canine Lymphoma and Canine Mast Cell Tumors.

Dr. Peter Urrea, OgenX's Chief Regulatory Officer stated that "this is a major milestone for the RC-2 Beta Drug Development Program and culminates the granting of two FDA Fee Waivers, the acceptance of the Investigational Animal Drug Application (INAD), successful completion of two NADA Pre-Submission Meetings in March and April 2013, the Submission of the two Requests for MUMS Designation (similar to Orphan Drug Status), and the formal submission of five protocols that will serve as the basis and support (safety and a reasonable expectation of effectiveness) for Conditional Approval of both indications through the NADA submission process.

Dr. Urrea went on to say "that these protocols include: the Clinical Pilot/Supportive Study Protocols for Canine Lymphoma and Canine Mast Cell Tumors, the Target Animal Safety Study in Beagle Dogs, the C-14 Adsorption, Distribution, Metabolism and Excretion Study (ADME), and the In-Vitro Growth Inhibition Cell Line Study. Importantly, based on our previous clinical and preclinical experience and our confidence in the safety and the effectiveness of RC-2 Beta in the treatment of Canine Lymphoma and Canine Mast Cell Tumors, all five of these studies will be implemented in parallel. We expect to have all protocols accepted by the CVM within the next 40-days making it possible to initiate our clinical study program at Texas A&M Veterinary Center for Oncology as early as September 2013."

The Texas A&M Institutional Animal Care and Use Committee has formally approved the protocols for both Canine Lymphoma and Canine Mast Cell Tumor Studies which will be conducted by Dr. Heather Wilson-Robles, DVM, DACVIM (Oncology), the Principal Investigator at the Veterinary Oncology Small Animal Clinical Sciences Department. The manufacturing of the cGMP RC-2 Beta Clinical Drug Supply is in process and will be completed by the end of August 2013.

OgenX's CEO, Dr. Richard Davis, stated that: "We are anticipating receipt of the MUMS Designations for both indications by the FDA's Office of Minor Uses / Minor Species (OMUMS) as early as August 2013. These Designations would permit us to file for grant applications for all five of the RC-2 Beta Studies during the FDA's window for summer grant applications. The target timeline for filing of the NADAs for Conditional Approval of Canine Lymphoma and Canine Mast Cell Tumors is 1Q2014. Conditional Approval would provide OgenX with the ability to commercialize RC-2 Beta for these two common fatal illnesses by mid-2014."


December 31, 2012 - OgenX Therapeutics to Present at BIOTECH Showcase 2013

December 31, 2012 - OgenXTM Therapeutics Corporation announced today that it has accepted an invitation to present the Company at the BIOTECH Showcase 2013 conference. The presentation is scheduled for January 9th at the Parc 55 Wyndham San Francisco Union Square at 4:15PM Mission II, Track C, on the 4th Level of the Cyril Magnin Foyer. Dr. Richard Davis (CEO) stated that "I am delighted to accept the invitation to present OgenX and our remarkable Redoxagen technology to the investor community and other distinguished guests attending this event."


December 28, 2012 - FDA Notifies OgenX Therapeutics of its Acceptance of the Investigational New Animal Drug Application for use of RC-2 beta in the Treatment of Canine Lymphosarcoma and Canine Mast Cell Tumors

December 28, 2012 - OgenXTM Therapeutics Corporation announced today that the FDA's Center for Veterinary Medicine has accepted the Company's Investigational New Animal Drug application to initiate clinical trials of its lead compound RC-2 beta for the treatment of Canine Lymphosarcoma and Canine Mast Cell Tumor. This action follows closely behind the FDA's MUMS designation and Fee Waivers for both indications earlier this month. OgenX is now in the queue for a pre-submission meeting in Q1 2013 where the terms of a Conditional Approval based on the exemptions available under the MUMS designation will be discussed. Dr. Richard Davis (CEO) stated that "We at OgenX are delighted that the FDA has moved so quickly with our request to bring RC-2 beta to the clinic. Based on our previous evidence, we have every confidence that this disruptive mitochondrial medicine will demonstrate its ability to help save the lives of many dogs suffering from these deadly cancers; and bring well-deserved hope to the families who love them." Dr. Peter Urrea, OgenX's Chief Regulatory Officer went on to say "This important milestone paves the way for a definitive clinical investigation under the fast track exemptions available to us under the MUMS designations we received previously."


December 14, 2012 - OgenX Therapeutics Files an Investigational New Animal Drug Application for use of RC-2 beta in the Treatment of Canine Lymphosarcoma and Canine Mast Cell Tumors

December 14, 2012 - OgenXTM Therapeutics Corporation announced today that it has filed an Investigational New Animal Drug application with the FDA to initiate clinical trials of its lead compound RC-2 beta for the treatment of Canine Lymphosarcoma and Canine Mast Cell Tumor. OgenX previously announced that it had received notification from the Center of Veterinary Medicine, Office of Minor Use and Minor Species Animal Drug Development (OMUMS), of Sponsor Fee Waiver for both indications which will substantially reduce the cost of development, as well as the time to market under the terms of a Conditional Approval based on the exemptions available under the MUMS designation. Dr. Richard Davis (CEO) stated that "we are very pleased that we have been successful in advancing our companion animal oncology program to this important INAD milestone." Dr. Peter Urrea, OgenX's Chief Regulatory Officer went on to say "I am delighted to have lead the company's regulatory effort in achieving this critical milestone in our Animal Health Division".


December 12, 2012 - OgenX Therapeutics Receives Notice of Fee Waiver and MUMS Designation from the FDA for its Lead Veterinary Development Compound RC-2 beta for the Treatment of Canine Mast Cell

December 12, 2012 - OgenXTM Therapeutics Corporation Announced today that it has received notice from the Center of Veterinary Medicine, Office of Minor Use and Minor Species Animal Drug Development (OMUMS), of Sponsor Fee Waiver for FY 2013 for its lead compound RC-2 beta, for treatment of canine mast cell tumor (MCT), based on the product being intended for a minor use in a major species (MUMS). OgenX estimates that the MUMS fee waiver could save OgenX as much as $435,200 for initial filing fees and $217,600 in supplemental filing fees. In addition, the MUMS designation provides for an acceleration of full commercialization subsequent to the receipt of a Conditional Approval that would become available upon CVM's acceptance of data from the planned Phase I study that would adequately demonstrate safety and the 'potential for efficacy'. Dr. Richard Davis (CEO) stated that "this third Fee Waiver and MUMS Designation is another in a series of significant milestone events for the company that demonstrates OgenX's commitment to the veterinary market along with our plan to push our lead veterinary compound forward to fulfill important unmet needs in canine oncology under very favorable financial terms to both the company and its investors."


December 12, 2012 - OgenX Therapeutics Receives Notice of Fee Waiver and MUMS Designation from the FDA for its Lead Veterinary Compound RC-2 beta for the Treatment of Canine Lymphosarcoma

December 12, 2012 - OgenXTM Therapeutics Corporation Announced today that it has received notice from the Center of Veterinary Medicine, Office of Minor Use and Minor Species Animal Drug Development (OMUMS), of Sponsor Fee Waiver for FY 2013 for its lead compound RC-2 beta, for treatment to alleviate signs and symptoms related to canine lymphosarcoma (CLS), based on the product being intended for a minor use in a major species (MUMS). OgenX estimates that the MUMS fee waiver could save OgenX as much as $435,200 for initial filing fees and $217,600 in supplemental filing fees. In addition, the MUMS designation provides for an acceleration of full commercialization subsequent to the receipt of a Conditional Approval that would become available upon CVM's acceptance of data from the planned Phase I study that would adequately demonstrate safety and the 'potential for efficacy'. Dr. Richard Davis (CEO) stated that "this is another important milestone event for the company that will facilitate OgenX's plan to significantly accelerate the commercial entry of our lead veterinary compound into the companion animal oncology market under very favorable financial terms to both the company and its investors."


October 1, 2012 - OgenX Therapeutics Receives Notice of Fee Waiver from FDA for its Lead Veterinary Compound RC-2 beta for the Treatment of Equine Herpesvirus-1 Myeloencephalophathy

October 1, 2012 - OgenXTM Therapeutics Corporation Announced today that it has received notice from the Center of Veterinary Medicine, Office of Minor Use and Minor Species Animal Drug Development (OMUMS), of Sponsor Fee Waiver for FY 2012 for its lead compound RC-2 beta, for treatment to alleviate neurological signs related to apparent Equine Herpesvirus-1 Myeloencephalopathy (EHM), based on the product being intended for a minor use in a major species (MUMS). OgenX estimates that the MUMS fee waiver could save the company as much as $435,200 for initial filing fees and $217,600 in supplemental filing fees. Dr. Richard Davis (CEO) stated that "this is a milestone event for the company that will facilitate OgenX's plan to push its lead veterinary compound forward under very favorable financial terms to both the company and its investors."




OGENX THERAPEUTICS' FORWARD-LOOKING STATEMENT

These press releases include forward-looking statements regarding OgenX's financial position and outlook and OgenX's business. Any statement describing OgenX's goals, expectations, financial or other projections, intentions or beliefs, including the planned commercialization of RC-1 alpha or RC-2 beta, or any other product candidate, is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for uses as human or animal therapeutics, and in the endeavor of building a business around such drugs. OgenX's forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although OgenX's forward-looking statement reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by OgenX. As a result, you are cautioned not to rely on these forward-looking statements. In this press release, unless the context requires otherwise, "OgenX", "Company", "we", "our" and "us" refers to OgenX Therapeutics Corporation. OgenXTM , RedoxagenTM, RC-1 alphaTM and RC-2 betaTM are trademarks of OgenX Therapeutics Corporation.