INNOVATING FOR PATIENTS
Nasdaq: TRVN I January 2023
Forward-Looking Statements
To the extent that statements contained in this presentation are not descriptions of historical facts regarding Trevena, Inc. (the "Company" or "we"), they are forward-looking statements reflecting management's current beliefs and expectations. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry's actual results, levels of activity, performance, or achievements to be materially different from those anticipated by such statements. You can identify forward-looking statements by terminology such as "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "objective," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should,"
"continue," "ongoing," or the negative of these terms or similar expressions. Forward-looking statements contained in this presentation include, but are not limited to, (i) statements regarding
the timing of anticipated clinical trials for our product candidates; (ii) the timing of receipt of clinical data for our product candidates; (iii) our expectations regarding the potential safety, efficacy, or clinical utility of our product candidates; (iv) the size of patient populations targeted by our product candidates and market adoption of our potential drugs by physicians and patients; (v) the timing or likelihood of regulatory filings and approvals; and (vi) our cash needs.
Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of our clinical trials or any future trials of any of our investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including our assessment of the discussions with the FDA or other regulatory agencies about any and all of our programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to our intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of our therapeutic candidates; and other factors discussed in the Risk Factors set forth in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings we make with the SEC from time to time. In addition, the forward-looking statements included in this presentation represent our views only as of the date hereof. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, except as may be required by law.
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Trevena's Experienced Leadership Team
SENIOR MANAGEMENT
Carrie L. Bourdow | President & Chief Executive Officer |
Mark A. Demitrack, M.D. | SVP, Chief Medical Officer |
Patricia Drake | SVP, Chief Commercial Officer |
Barry Shin | SVP, Chief Financial Officer |
Robert T. Yoder | SVP, Chief Business Officer & Head |
of Commercial Operations | |
BOARD OF DIRECTORS
Leon O. Moulder, Jr. Chairman | Marvin H. Johnson, Jr. |
Carrie L. Bourdow | Jake R. Nunn |
Scott Braunstein, M.D. | Anne M. Phillips, M.D. |
Michael R. Dougherty | Barbara Yanni |
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Trevena: Innovative CNS Company
IV OLINVYK: | NCE approved for the management of acute pain in adults |
Differentiated profile | Launch in Q1 2021; additional supportive studies vs. IV morphine with near-term data |
Large market, | 45M+ US hospital patients; 9M procedures is initial core focus |
targeted launch | $1.5B+ market opportunity for core focus |
TRV045: | Novel candidate for CNS disorders (with potential broader applicability) |
Selective S1PR modulator | Phase 1 study completed; proof-of-concept study initiated |
Novel | New mechanisms for acute / neuropathic pain, epilepsy, acute migraine, opioid use disorder |
CNS pipeline | NCEs targeting significant unmet needs |
Solid | $40.4M cash / equivalents / marketable securities @ Q3 |
financial position | $8M Registered Direct financing in November 2022 |
OLINVYK is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information at www.OLINVYK.com.
NCE = New Chemical Entity; MOA = Mechanism of Action; NIH = National Institutes of Health; | 4 |
IV
Multiple Expected Catalysts
PRE-CLIN | PHASE 1 | PHASE 2 | PHASE 3 | NDA | POST-APPR | |||
IV acute pain* | APPROVED | |||||||
Leiden UMC collab. | Respiratory physiology | |||||||
OLINVYK® | ||||||||
New chemical entity | Center for Human Drug Research, Leiden | Cognitive function | ||||||
(mu-opioid receptor) |
EXPECTED CATALYSTS
- Commercial launch ongoing
- Topline data released March 2022
- Topline data released July 2022
Cleveland Clinic / Wake Forest Baptist Health collab. Clinical outcomes | • Enrollment complete 2H 22 | |||
Nhwa NDA Submission in China | • NDA Submitted | |||
TRV045 | DNP | • Phase 1 complete | ||
Selective S1P | • PoC study initiated | |||
receptor modulator | Epilepsy | NIH collab. | • Epilepsy data announced | |
TRV250 | Acute migraine | • IND-enabling activities (oral) | ||
G-protein selective agonist | ||||
(delta receptor) | ||||
TRV734 | Opioid use disorder | NIH / NIDA collab. | • POC study ongoing | |
G-protein selective agonist | ||||
(mu-opioid receptor)
OLINVYK is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. * Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information at www.OLINVYK.com.
TRV250, TRV734 and TRV045 are investigational products and are not approved by the FDA or any other regulatory agency.; NDA = New Drug Application, PoC = Proof-of-Concept, DNP = Diabetic
Neuropathic Pain | 5 |
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Trevena Inc. published this content on 06 January 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 January 2023 12:48:04 UTC.