Trethera Announces Prostate Cancer Poster Presentation at the American Association for Cancer Research Annual Meeting

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Los Angeles, March 22, 2022 — Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announced an upcoming poster presentation at the American Association for Cancer Research (AACR) Annual Meeting.  Dr. Caius Radu, of the University of California Los Angeles, will present preclinical research highlighting the use of the deoxycytidine kinase (dCK) inhibitor, TRE-515, to selectively inhibit the growth of prostate cancer cells in xenograft mouse models that rely on dCK for DNA synthesis and rapid malignant proliferation.  AACR is one of the largest annual meetings of cancer researchers and a key venue for presenting noteworthy oncology discoveries.  Accordingly, the first-in-class molecule TRE-515 is currently being evaluated in a Phase 1 open-label, dose escalation study in solid tumors. 

Presentation Details:

Title: Inhibiting deoxycytidine kinase significantly inhibits tumor growth in xenograft models of castration resistant prostate cancer
Authors: Caius G. Radu, MD; Kenneth A. Schultz, MD; Katharina Lückerath, PhD; H. Michael Shepard, PhD; Johannes Czernin, MD
Date: Tuesday, April 12, 2022; 9:00 AM – 12:30 PM
Abstract: 2635

TRE-515 is an orally delivered therapeutic engineered to inhibit dCK, the key enzyme in the nucleoside salvage pathway.  A common characteristic of solid tumors is that they require elevated levels of nucleotides to support rapid cellular DNA replication necessary for accelerated malignant growth.  Cancer cells overexpress dCK to help maintain these elevated nucleotide levels.  In contrast, dCK activity is highly restricted in healthy adult human cells.  By targeting dCK, scientists hope to selectively and effectively deprive cancer cells of this needed nucleotide source, thereby blocking tumor growth.

About Trethera

Trethera is a clinical stage privately held biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members. Trethera’s innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally taken capsule twice designated by the FDA as an Orphan Drug.  TRE-515 is a first-in-class clinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors.  It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth.  Certain autoimmune diseases might also respond to TRE-515 treatment.  Trethera is developing TRE-515 for use as a monotherapy or in combination, to precisely target a metabolic vulnerability of cancer or autoimmune diseases that will transform outcomes for patients.

For more information, please visit us at trethera.com.

Note on Forward-Looking Statements 

All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. Trethera intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.

Safety Review Committee Advances Trethera Phase 1 Solid Tumors Trial to Next Dose After First Patient Cohort Achieves Primary Endpoint

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Los Angeles, December 9, 2021 — Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announced that the first patient cohort completed their full dose cycle with no serious adverse events (SAEs) in its multi-site Phase 1 oncology trial. The safety and tolerability of TRE-515, a first-in-class drug targeting the enzyme deoxycytidine kinase (dCK), is being evaluated in up to 36 patients with various solid tumor malignancies.

No SAEs and no drug-related treatment-emergent adverse events were observed during the administration of TRE-515 as a monotherapy treatment. The independent safety review committee (SRC) evaluated the first cohort data and unanimously supported study continuation and dose escalation. The clinical trial will now proceed to the second of five dose levels, and interim data is expected by the end of next year. “We are pleased to have the SRC endorsement for dose escalation and to reach this milestone in TRE-515 development,” said Dr. Ken Schultz, Trethera Chairman and CEO. “We are grateful to the patients and clinical sites for their participation and look forward to continued collaboration as we commence enrollment of the second cohort.”

TRE-515 is an orally delivered therapeutic engineered to inhibit dCK, the key enzyme in the nucleoside salvage pathway. A common characteristic of solid tumors is that they require elevated levels of nucleotides to support rapid cellular DNA replication and accelerated malignant growth. Cancer cells overexpress dCK to help maintain these elevated nucleotide levels. In contrast, dCK activity is highly restricted in healthy adult human cells. By targeting dCK, scientists hope to selectively and effectively deprive cancer cells of this needed nucleotide source, thereby blocking tumor progression.

About Trethera

Trethera is a clinical stage privately held biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members. Trethera’s innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally taken capsule twice designated by the FDA as an Orphan Drug. TRE-515 is a first-in-class clinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors. It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth. Certain autoimmune diseases might also respond to TRE-515 treatment. Trethera is developing TRE-515 for use as a monotherapy or in combination, to precisely target a metabolic vulnerability of cancer or autoimmune diseases that will transform outcomes for patients.

For more information, please visit us at trethera.com.

Note on Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. Trethera intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.

Trethera Announces FDA Orphan Drug Designation Granted to TRE-515 for the Treatment of Demyelinating Optic Neuritis

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Los Angeles, November 12, 2021 — Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Status (ODS) to TRE-515 for the treatment of optic neuritis (ON). ON is a rare autoimmune disease where patients rapidly lose vision in one or both eyes with 1 in 10 patients never fully recovering their eyesight. TRE-515 is a first-in-class drug targeting the enzyme deoxycytidine kinase (dCK).

“The FDA designation for the treatment of ON complements our existing exclusive ODS for acute disseminated encephalomyelitis (ADEM) and provides key external validation that continues to showcase the strength of our scientific data,” said Dr. Ken Schultz, Trethera Chairman and CEO. “TRE-515 is developing an impressive resume for potential treatments of demyelinating autoimmune diseases.” ADEM is an autoimmune disease in which the immune system damages myelin in the central nervous system, leading patients to become paralyzed and causing death in some cases.

Over 100,000 cases of ON occur annually in the US and have a close association with multiple sclerosis (MS). Although steroids accelerate the rate of ON recovery and limit conversion to MS in the first two years, steroids have no effect on long-term visual outcomes or conversion to MS as measured after 5 years. “Inflammation damaging the protective myelin coating around the optic nerve causes ON, leading to pain and vision loss. Targeting dCK with TRE-515 could limit this inflammation,” said Dr. Peter Clark, member of the Trethera Scientific Advisory Board.

“For some patients, ON can be self-resolving, but for others ON can lead to lifelong disability. In all ON cases, the threat of future conversion to MS remains. Any drug that could improve these outcomes for patients would be game changing. TRE-515 could potentially significantly benefit ON patients beyond the available therapeutic options, especially those taking long-term steroids,” said Trethera Scientific Advisory Board member Dr. Larry Steinman.

The FDA’s Orphan Drug program is designed to advance the development of drugs that treat a condition affecting 200,000 or fewer US patients annually. ODS is given to medicinal products that represent a significant benefit over existing treatments and are intended for the treatment of a disease that is life-threatening or chronically debilitating. The ODS designation qualifies Trethera for certain incentives, which include FDA assistance in designing clinical trials, access to the FDA Orphan Drug Grants Program, exemption from the drug approval application fee and eligibility for seven years of marketing exclusivity.

Sources: Bennett 2019; Cleveland Clinic 2021; Yang 2017; Wilhelm 2015

About Trethera

Trethera is a clinical stage privately held biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members. Trethera’s innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally taken capsule designated by the FDA as an Orphan Drug. TRE-515 is a first-in-class clinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors. It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth. Certain autoimmune diseases might respond to TRE-515 treatment. Trethera is developing TRE-515 for use as a monotherapy or in combination, to precisely target a metabolic vulnerability of cancer cells or autoimmune diseases that will transform outcomes for patients.

For more information, please visit us at trethera.com.

Note on Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.

Trethera Doses First Patient in Landmark Clinical Trial for the Treatment of Solid Tumors With First-In-Class Drug TRE-515

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Los Angeles, October 15, 2021 — Trethera Corporation (“Trethera”), a biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announced that the first patient has been treated with TRE-515, a first-in-class inhibitor of deoxycytidine kinase (dCK). Trethera’s multi-site Phase 1 study will evaluate TRE-515 monotherapy in up to 36 patients with various solid tumors.

“I am thrilled to announce the world’s first clinical stage dCK inhibitor, TRE-515” said Dr. Ken Schultz, Trethera Chairman and CEO. “This study will assess the safety and tolerability of TRE-515, as well as utilize multiple biomarkers to measure target engagement, a valuable tool for predicting antitumor activity in the clinic. We look forward to sharing future updates as the clinical trial progresses.”

“The first patient dosed marks a significant milestone toward delivering on the promise and potential of an exciting new clinical treatment strategy targeting dCK,” said Dr. Michael Shepard, Lasker Laureate and member of the Trethera Scientific Advisory Board. “TRE-515 is a one-of-a-kind small molecule inhibitor that has the potential to durably treat devastating diseases such as cancer and multiple sclerosis.”

Trethera’s US-based clinical trial evaluates the safety and tolerability of TRE-515 in patients with various solid tumor malignancies. A common characteristic of solid tumors is the rapid cellular DNA replication necessary to enable accelerated malignant growth. TRE-515 is an orally delivered therapeutic engineered to inhibit dCK, the key enzyme in a nucleotide metabolism pathway shown to be overexpressed in cancer cells. By targeting dCK, scientists hope to selectively and effectively deprive cancer cells of a needed additional source of nucleotides, thereby blocking DNA replication and halting tumor progression.

“For years, Trethera has had an unwavering commitment to advancing nucleotide metabolism treatments,” said Dr. Caius Radu, co-founder and primary inventor. “With the first patient treated in this historic clinical trial, we mark a significant step in advancing the TRE-515 clinical program and move closer to our goal of developing a game-changing medicine for patients with cancer and autoimmune diseases.”

“TRE-515 is intelligently designed and on target, knocking out dCK, which could be a key to stopping the growth of certain tumors or modulating select autoimmune diseases,” said Dr. Owen Witte, co-founder and Scientific Advisory Board member. “Advancing a first-in-class drug from bench to bedside represents a remarkable scientific achievement.”

About Trethera

Trethera is a clinical stage privately held biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members. Trethera’s innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally taken capsule designated by the FDA as an Orphan Drug. TRE-515 is a first-in-class clinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors. It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth. Certain autoimmune diseases might respond to TRE-515 treatment. Trethera is developing TRE-515 for use as a monotherapy or in combination, to precisely target a metabolic vulnerability of cancer cells or autoimmune diseases that will transform outcomes for patients.

For more information, please visit us at trethera.com.

Note on Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.

Globally Recognized Multiple Sclerosis Expert, Dr. Lawrence “Larry” Steinman, Joins Trethera Scientific Advisory Board

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Los Angeles, May 25, 2021 —Trethera Corporation (Trethera), a biopharmaceutical company committed to developing novel drugs targeting cellular nucleotide metabolism for the treatment of cancers and autoimmune diseases, is pleased to announce the appointment of renowned autoimmunity researcher Dr. Larry Steinman to its Scientific Advisory Board.  Dr. Steinman will be advising Trethera regarding TRE-515 development, a first-in-class compound with the potential to treat multiple sclerosis (MS) and other autoimmune neurologic diseases. 

Dr. Steinman is currently a professor of Neurology and Neurological Sciences, Pediatrics, and Genetics at Stanford University and leads a research team focused on autoimmune diseases.  He is a recipient of numerous honors and awards, including the John M. Dystel Prize awarded jointly by the National Multiple Sclerosis Society and the American Academy of Neurology for his research on MS, the Charcot Prize for Lifetime Achievement in MS research and the Cerami Prize for Translational Research. Dr. Steinman is also a member of both the National Academy of Sciences, and the National Academy of Medicine.  Dr. Steinman coauthored the groundbreaking 1992 Nature article describing Tysabri, a multiple sclerosis and Crohn’s therapeutic now approved in over 80 countries and taken by over 200,000 MS patients.

“We are honored and proud to have Dr. Steinman’s expertise and inputs with our Scientific Advisory Board,” said Dr. Ken Schultz, Trethera Chairman and CEO.  “He is a leading authority on autoimmune diseases, with over 40 years’ experience treating and researching MS.  He joins us at a pivotal period, as we migrate from our preclinical proof-of-concept data and FDA Orphan Drug designation, into clinical development planning. Dr. Steinman’s expertise will be invaluable to our efforts to establish TRE-515 as a treatment option for patients fighting this debilitating disease.”

“I came to Trethera initially skeptical that TRE-515 could bring value to multiple sclerosis patients beyond the available therapeutic options,” said Dr. Steinman. “However, I was won over by the compelling data presented combined with the world-renown team Trethera has put together to advance this work. I am convinced that TRE-515 has the potential to positively impact MS patients and am excited to work with the team as this compound progresses toward the clinic.”

Reference: Nature, March 5, 1992, Volume 356.5

About Trethera

Trethera is a preclinical stage privately held biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members.

Trethera’s innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally taken capsule designated by the FDA as an Orphan Drug. TRE-515 is a first-in-class preclinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors. It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth. Certain autoimmune diseases might respond to TRE-515 treatment. Trethera is developing TRE-515 for use as a monotherapy or in combination, to precisely target a metabolic vulnerability of cancer cells or autoimmune diseases that will transform outcomes for patients.

Note on Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.

Trethera Receives FDA Approval To Initiate TRE-515 Phase 1 Clinical Trial in Solid Tumors Monotherapy

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Los Angeles, April 19, 2021— Trethera Corporation (Trethera), a biopharmaceutical company committed to developing novel drugs targeting cellular nucleotide metabolism for the treatment of cancer and autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) has approved its TRE-515 investigational new drug (IND) application for the treatment of solid tumor malignancies.  Trethera will now begin the site activation process with the University of Los Angeles (UCLA) as well as other US based sites where health innovation is a key focus.

“Receiving regulatory approval to initiate a phase 1, first-in-human clinical trial with an innovative, first-in-class oral inhibitor of deoxycytidine kinase (dCK), the key enzyme in the nucleotide salvage pathway, is a landmark clinical development.  It adds another potential weapon to our therapeutic arsenal against solid tumors,” said Dr. Zev Wainberg, UCLA Professor of Medicine, and Co-Director of the GI Oncology Program, and Director Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center. “We are especially excited that this protocol includes advanced diagnostics that will enable us to readily measure the drug impact on malignant progression.”   Dr. Wainberg will be the principal investigator for the trial that will enroll cancer patients with a wide range of solid tumors. 

The Phase I open-label, dose escalation study is expected to enroll the first patient in the final quarter of 2021.  The overall goal will be to evaluate safety, pharmacokinetics, and establish a recommended phase 1b/2 starting dose.  The protocol includes measuring deoxycytidine (dC), the dCK substrate, as well as utilizing a specialized PET probe to measure intracellular dCK as the drug target.  “As multiple tumor types upregulate dCK in response to increased DNA synthesis needs, TRE-515 has the potential for multi-tumor anticancer activity alone, or in combination with other established or developing therapeutics,“ said Dr. Ken Schultz, Trethera Chairman and CEO.   

About Trethera

Trethera is a preclinical stage privately held biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members.

Trethera’s innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally taken capsule designated by the FDA as an Orphan Drug. TRE-515 is a first-in-class preclinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors. It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth. Certain autoimmune diseases might respond to TRE-515 treatment. Trethera is developing TRE-515 for use as a monotherapy or in combination, to precisely target a metabolic vulnerability of cancer cells or autoimmune diseases that will transform outcomes for patients.

Note on Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.

Trethera Announces Jefferies & Company Chairman Emeritus Frank Baxter as Special Advisor

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Los Angeles, March 16, 2021— Trethera Corporation (“Trethera”), a biopharmaceutical company committed to developing novel drugs targeting cellular nucleotide metabolism for the treatment of cancer and autoimmune diseases announces that Frank Baxter has been appointed as special advisor. He will be advising Trethera and its board of directors on financing options including private equity, public equity and debt obligations.

Frank Baxter is Chairman Emeritus of the global investment bank Jefferies & Company Inc. (NYSE: JEF) and served as US Ambassador to Uruguay from November 2006 to January 2009. “We are excited to have Frank participating as a special advisor to our company,” said Dr. Jean DeKernion, President of Trethera. “Ambassador Baxter is among the original outside investors in Trethera. His wealth of experience will be invaluable in exploring the most beneficial financing options for our company and its stockholders as we drive toward clinical trial entry. On behalf of the entire company, we welcome him to the team.”

Ambassador Baxter joined Jefferies in 1974 and became its CEO in 1987 succeeding its founder, Boyd L. Jefferies. Under Baxter’s leadership, the company focused on diversification beyond block equity trading. In the 1990s, he made key decisions to expand Jefferies’ bond trading group as well as increase its investment banking presence. Ambassador Baxter’s push into investment banking led to over $20B capital raised for mid-sized companies. In 2002, he retired as CEO after 14 years in the position. Today Jefferies has over $45B in total assets.

Ambassador Baxter is the former director of the NASD and served as Chairman of the Committee, which resulted in the spin-off of NASDAQ. He subsequently served on the Board of NASDAQ as a member of the Executive Committee and Chairman of the CEO search committee. Ambassador Baxter is also a former director of the Securities Industry Association. He currently participates on numerous boards in Southern California for non-profit organizations and educational institutions, including the St. John’s Health Center Foundation, the University of California Berkeley Foundation and the Los Angeles County Museum of Art. Ambassador Baxter is the recipient of the Bet Tzedek House of Justice Award and the City of Angels award. He graduated from the University of California at Berkeley with a Bachelor of Arts degree in economics.

About Trethera

Trethera is a preclinical stage privately held biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members.

Trethera’s innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally taken capsule designated by the FDA as an Orphan Drug. TRE-515 is a first-in-class preclinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors. It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth. Certain autoimmune diseases might respond to TRE-515 treatment. Trethera is developing TRE-515 for use as a monotherapy or in combination, to precisely target a metabolic vulnerability of cancer cells or autoimmune diseases that will transform outcomes for patients.

Note on Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.

Trethera Announces Completion of $3.2 Million Seed Funding Round From Current Investors

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Los Angeles, February 24, 2021— Trethera Corporation (“Trethera”), a biopharmaceutical company committed to developing novel drugs targeting cellular nucleotide metabolism for the treatment of cancer and autoimmune diseases, is pleased to announce completion of its Seed Preferred 3 Stock financing.  Trethera raised an aggregate of $3.2 million from its existing investors, which funds will be used for working capital purposes.

“Raising this amount of capital from current stockholders further signifies Trethera’s momentum, be it from TRE-515 achieving Orphan Drug status or the prosecution of new patents,” said Dr. Kenneth Schultz, Chairman and CEO of Trethera. “Beyond the dollar amount, that many people tend to focus on, are the long-term investors who come with incredible business expertise. Over the past year Trethera has attracted world class talent, with a team of esteemed scientific experts and advisors. Our investors are enthusiastic about Trethera’s multidimensional drug TRE-515 entering clinical trials.”

Trethera’s strategy is to create a highly attractive and differentiated approach for the treatment of cancers and autoimmune diseases with TRE-515. The company is leveraging new insights into metabolic pathways to advance novel treatment strategies. “I am excited by the opportunity to help advance medicines that could significantly impact how people with these diseases are treated,“ concluded Dr. Schultz.

About Trethera

Trethera is a preclinical stage privately held biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members. Trethera’s innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally taken capsule designated by the FDA as an Orphan Drug.  TRE-515 is a first-in-class preclinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors.  It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth.  Certain autoimmune diseases might respond to TRE-515 treatment.  Trethera is developing TRE-515 for use as a monotherapy or in combination, to precisely target a metabolic vulnerability of cancer cells or autoimmune diseases that will transform outcomes for patients.

For more information, please visit us at trethera.com.

Note on Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.

Trethera Announces FDA Orphan Drug Designation Granted to TRE-515 in the Treatment of Acute Disseminated Encephalomyelitis

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Los Angeles, January 7, 2021— Trethera Corporation (“Trethera”), a biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Status (ODS) to TRE-515, Trethera’s first-in-class drug for the treatment of acute disseminated encephalomyelitis (ADEM).  ADEM is a rare autoimmune disease where patients lose their nerve function and become paralyzed, causing death in some cases.

“The symptoms of ADEM involve a severe bout of inflammation in the central nervous system that can include the brain, spinal cord, and sometimes the optic nerves. The inflammation damages myelin, the protective substance that coats nerve fibers throughout the central nervous system. No medications have been specifically approved by the FDA to treat it.” said Dr. Peter Clark, a specialist member of the Trethera Scientific Advisory Board. “Holding ODS at this early preclinical stage is a mark of distinction and external validation. The ODS designation qualifies Trethera for certain incentives, which include FDA assistance in designing clinical trials, access to the FDA Orphan Drug Grants Program, exemption from the drug approval application fee and eligibility for seven years of marketing exclusivity.”

About Trethera

Trethera is a preclinical stage privately held biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members. Trethera’s innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally taken capsule designated by the FDA as an Orphan Drug.  TRE-515 is a first-in-class preclinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors.  It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth.  Certain autoimmune diseases might respond to TRE-515 treatment.  Trethera is developing TRE-515 for use as a monotherapy or in combination, to precisely target a metabolic vulnerability of cancer cells or autoimmune diseases that will transform outcomes for patients.

Note on Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.

Globally Renowned Research Scientist Dr. Michael Shepard Joins Trethera’s Scientific Advisory Board

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Los Angeles, December 8, 2020— Trethera Corporation (“Trethera”), a biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, is pleased to announce that distinguished researcher Michael Shepard, PhD has joined Trethera’s Scientific Advisory Board. Dr. Shepard is a recipient of numerous biotechnology patents and scientific awards for his contributions to the development of innovative therapies including the prestigious Lasker-DeBakey Clinical Medical Research Award in 2019. Founded in 1945, the Lasker-DeBakey award is widely regarded as a top global biomedical research prize.

“We are honored to have Dr. Shepard join Trethera’s Scientific Advisory Board. Dr. Shepard is an internationally recognized industry pioneer who has helped develop breakthrough autoimmune and cancer therapies such as Herceptin,” said Dr. Kenneth Schultz, Chairman and CEO of Trethera. “Dr. Shepard joins us at an exciting time as we continue to develop TRE-515, our first-in-class dCK inhibitor for multiple indications. He has deep experience expanding cancer drugs to treat inflammatory and autoimmune diseases”.

Dr. Shepard, currently the President and CEO of Enosi Life Sciences, is best known for his pioneering work at Genetech where he led the team that discovered the antibody that attacks HER2-tumor cells that later became known as Herceptin. Herceptin is a life-saving therapy for women with breast cancer, reducing the risk of recurrence while extending survival times. While still at Genetech, Dr. Shepard also collaborated with fellow renowned researcher Sir Marc Feldmann, to develop Remicade, a TNF inhibitor now used to treat multiple autoimmune diseases. Dr. Shepard is also a recipient of the Warren Alpert Foundation Prize from the Harvard Medical School, a significant award given to scientists whose achievements have led to the prevention, cure or treatment of human diseases.

“At this juncture in my career I continually have the opportunity to be selective and work on therapies that show promise. I am very excited to be chosen to work with the Trethera team,” said Dr. Shepard. “I have found that Trethera’s small molecule inhibitor of deoxycytidine kinase, TRE-515, is an encouraging development with the potential to treat autoimmune diseases such as multiple sclerosis and certain forms of cancer. I look forward to lending expertise and advising them on their path toward clinical trials.”

About Trethera

Trethera is a preclinical stage privately held biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members. Trethera’s innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally taken capsule. TRE-515 is a first-in-class preclinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors. It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth. Certain autoimmune diseases might respond to TRE-515 treatment. Trethera is developing TRE-515 for use as a monotherapy or in combination, to precisely target a metabolic vulnerability of cancer cells or autoimmune diseases that will transform outcomes for patients.

Note on Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements” which may often, but not always, be identified by the use of such words as “may”, “might”, “will”, “will likely result”, “would”, “should”, “estimate”, “plan”, “project”, “forecast”, “intend”, “expect”, “anticipate”, “believe”, “seek,” “continue”, “target” or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.