UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
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Item 8.01 |
Other Events. |
On July 6, 2021, UNITY Biotechnology, Inc. (“UNITY” or the “Company”) announced positive data from its Phase 1 safety study of UBX1325 in patients with advanced disease from diabetic macular edema (DME) or wet or neovascular age-related macular degeneration (AMD) for whom anti-VEGF therapy was no longer considered beneficial. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
On July 6, 2021, the Company also posted a presentation on data from its Phase 1 safety study of UBX1325 in patients with advanced disease from DME or AMD for its investor call on its website. A copy of the presentation is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference herein.
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Item 9.01 |
Financial Statements and Exhibits. |
Reference is made to the Exhibit Index attached hereto.
Forward-Looking Statements
Any statements contained in this Form 8-K regarding matters that are not historical facts are “forward looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: UNITY’s understanding of cellular senescence and the role it plays in diseases of aging, the potential for UNITY to develop therapeutics to slow, halt, or reverse diseases of aging, including for ophthalmologic and neurologic diseases, the Company’s expectations regarding potential benefits, activity, effectiveness, and safety of its drug candidates, including UBX1325, the potential for UNITY to successfully commence and complete clinical studies, including those of UBX1325 for DME, AMD, and other ophthalmologic diseases, and the expected timing of results of studies including the Phase 2a study of UBX1325. These statements involve substantial known and unknown risks, uncertainties, and other factors that may cause the Company’s actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements, including the risk that the COVID-19 worldwide pandemic may continue to negatively impact the development of preclinical and clinical drug candidates, including delaying or disrupting the enrollment of patients in clinical trials, risks relating to the uncertainties inherent in the drug development process, and risks relating to UNITY’s understanding of senescence biology. The Company may not actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements, and no undue reliance on the Company’s forward-looking statements should be placed. Actual results or events could differ materially from the plans, intentions, and expectations disclosed in the forward-looking statements the Company makes. The forward-looking statements in this Form 8-K represent the Company’s views as of the date of this release. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of UNITY in general, see UNITY’s most recent Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, filed with the Securities and Exchange Commission on May 11, 2021, as well as other documents that may be filed by UNITY from time to time with the Securities and Exchange Commission. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this Form 8-K. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made except as required by applicable law.
EXHIBIT INDEX
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Description |
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99.1 |
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99.2 |
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Presentation of UNITY Biotechnology, Inc. dated July 6, 2021 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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UNITY BIOTECHNOLOGY, INC. |
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Date: July 6, 2021 |
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/s/ Anirvan Ghosh |
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Anirvan Ghosh, Ph.D. |
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Chief Executive Officer |
Exhibit 99.1
UNITY Biotechnology Announces Positive Data from Phase 1 Clinical Trial of UBX1325 in Patients with Advanced Vascular Eye Disease
Improvement in Visual Acuity and Central Subfield Thickness observed in diabetic
macular edema (DME) and wet age-related macular degeneration (wet AMD) patients
treated with UBX1325
UBX1325 advances to Phase 2a study in DME patients as a potential alternative to anti-VEGF therapies
UNITY to host conference call today at 8:00 a.m. ET
SOUTH SAN FRANCISCO, Calif., July 6, 2021 – UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced positive data from its Phase 1 safety study of UBX1325 in patients with advanced disease from DME or wet AMD for whom anti-VEGF therapy was no longer considered beneficial. UBX1325, a small molecule inhibitor of Bcl-xL and the first senolytic therapeutic evaluated in an ophthalmological clinical study, was well-tolerated with no treatment-related adverse events or dose-limiting toxicities. Additionally, the majority of DME and wet AMD patients treated with a single injection of UBX1325 demonstrated rapid improvements in best-corrected visual acuity (BCVA), central subfield thickness (CST), and sub- and intra-retinal fluid (SRF, IRF), all key clinical measures of disease progression.
The first patient has been dosed in a Phase 2a clinical study to assess the safety and efficacy of UBX1325 in a broader population of patients with DME, and data is expected in the first half of 2022. In addition, UNITY is enrolling additional patients with advanced wet AMD in the Phase 1 study to gather additional data to support a Phase 2a study in wet AMD. These studies are expected to generate data to inform the efficacy of UBX1325 in a wider range of patient populations, including those who are refractory to anti-VEGF treatment.
“We are very excited by the initial efficacy we see with UBX1325, including improvements in vision and structure in advanced patients, which suggest that UBX1325 may benefit a wide range of patients suffering from DME or wet AMD,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “UBX1325 targets an entirely novel mechanism to eliminate senescent cells in the retinal and choroidal vasculature, a potential root cause of disease progression, and could provide a valuable alternative or adjunctive treatment option to anti-VEGF therapies. We look forward to several important data readouts in the coming year that will further inform the optimal treatment regimen for UBX1325 in patients with DME and wet AMD.”
“The imaging data demonstrating structural improvements in the retina are compelling at this stage of clinical development and represent defined endpoints for disease improvement,” said Jeffrey Heier, M.D., Director of the Vitreoretinal Service and Retina Research at Ophthalmic Consultants of Boston. “Importantly, UBX1325 is an entirely new treatment modality for eye
disease and is particularly exciting for this patient population for whom new therapeutic options could provide significant additional benefits alone or in combination with anti-VEGF agents.”
The Phase 1, first-in-human, open-label, single-ascending dose study included 12 patients with advanced DME or wet AMD who were no longer expected to benefit from anti-VEGF therapies. UBX1325 was well tolerated in this patient population and demonstrated a favorable acute safety profile supporting further clinical development. There were no dose-limiting toxicities observed, with two nonserious, nondrug-related adverse events reported. In addition, patients treated with UBX1325 had improvements in vision and retinal structure as summarized below.
Treatment of patients with UBX1325 resulted in the following clinical changes as of June 30, 2021:
Gain in ETDRS Letters from Baseline in Best-Corrected Visual Acuity (BCVA)
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Overall (across all doses): 10 of 12 patients showed a gain in ETDRS letters from baseline in BCVA at 2 weeks; 9 of 12 patients showed a gain at 4 weeks |
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In high dose groups (5, 10 mcg): 6 of 6 patients showed a gain in ETDRS letters from baseline in BCVA at 2 weeks; 5 of 6 patients showed a gain at 4 weeks |
Decrease in Central Subfield Thickness (CST)
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Overall (across all doses): 6 of 12 patients had a decrease (improvement) in CST at 2 weeks; 5 of 12 patients showed reductions at 4 weeks |
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In high dose groups (5, 10 mcg): 4 of 6 patients showed decrease in CST at 2 weeks; 3 of 6 patients showed reductions at 4 weeks |
Reduction in Subretinal / Intraretinal Fluid
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3 of 4 patients with wet AMD had a reduction in subretinal / intraretinal fluid (SRF / IRF), and improvement in disease-relevant pathology |
Jamie Dananberg, M.D., chief medical officer of UNITY, added, “The patients enrolled in this study had advanced disease for whom anti-VEGF therapies, the standard of care for DME and wet AMD, were no longer thought to be of benefit. Seeing treatment-related improvement in these difficult-to-treat patients is very promising and supports the investigation of UBX1325’s potential as a differentiated, disease-modifying treatment option for a broad patient population. We look forward to further exploring the efficacy of this novel mechanism to alter the course of disease progression in DME patients in the recently initiated Phase 2a study.”
Conference Call Information
UNITY will host a conference call and webcast for investors on Tuesday, July 6th at 8:00 a.m. ET to discuss the UBX1325 clinical data. The live webcast can be accessed in the “Investors and Media” section of our website, www.unitybiotechnology.com, under “Events & Presentations” or by clicking here. You may also listen to the call by dialing (877) 235-8637 within the U.S. or (704) 815-6400 outside the U.S. and providing conference ID 9423419. A replay will be available two hours after the completion of the call and can be accessed in the “Investors & Media” section of our website, under “Events and Presentations.”
About UBX1325
UBX1325 is an investigational compound being studied for age-related diseases of the eye, including diabetic macular edema (DME), age-related macular degeneration (AMD), and diabetic retinopathy that is not approved for any use in any country. UBX1325 is a potent small molecule inhibitor of Bcl-xL, a member of the Bcl-2 family of apoptosis regulating proteins. UBX1325 is designed to inhibit the function of proteins that senescent cells rely on for survival. In preclinical studies, UNITY has demonstrated that targeting Bcl-xL with UBX1325 preferentially eliminated senescent cells from diseased tissue while sparing cells in healthy tissue. UNITY’s goal with UBX1325 is to transformationally improve real-world outcomes for patients with DR, DME, and AMD.
About UNITY
UNITY is developing a new class of therapeutics to slow, halt, or reverse diseases of aging. UNITY’s current focus is on creating medicines to selectively eliminate or modulate senescent cells and thereby provide transformative benefit in age-related ophthalmologic and neurologic diseases. More information is available at www.unitybiotechnology.com or follow us on Twitter and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements including statements related to UNITY’s understanding of cellular senescence and the role it plays in diseases of aging, the potential for UNITY to develop therapeutics to slow, halt, or reverse diseases of aging, including for ophthalmologic and neurologic diseases, our expectations regarding potential benefits, activity, effectiveness, and safety of UBX1325, the potential for UNITY to successfully commence and complete clinical studies of UBX1325 for DME, AMD, and other ophthalmologic diseases, the expected timing of results of our studies of UBX1325, the timing of the expected commencement, progression, and conclusion of our studies including those of UBX1325, and UNITY’s expectations regarding the sufficiency of its cash runway. These statements involve substantial known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements, including the risk that the COVID-19 worldwide pandemic may continue to negatively impact the development of preclinical and clinical drug candidates, including delaying or disrupting the enrollment of patients in clinical trials, risks relating to the uncertainties inherent in the drug development process, and risks relating to UNITY’s understanding of senescence biology. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions, and expectations disclosed in the forward-looking statements we make. The forward-looking statements in this press release represent our views as of the date of this release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this release. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of UNITY in general, see UNITY’s most recent Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, filed with
the Securities and Exchange Commission on May 11, 2021, as well as other documents that may be filed by UNITY from time to time with the Securities and Exchange Commission.
Media
Canale Communications
Jason Spark
jason.spark@canalecomm.com
1 UBX1325 Phase 1 Data Conference Call July 6th, 2021 Anirvan Ghosh, CEO Jamie Dananberg, CMO Lynne Sullivan, CFO Exhibit 99.2
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS 2 This presentation and the accompanying oral commentary contain forward-looking statements including statements related to UNITY’s understanding of cellular senescence and the role it plays in diseases of aging, the potential for UNITY to develop therapeutics to slow, halt, or reverse diseases of aging, including for ophthalmologic and neurologic diseases, our expectations regarding potential benefits, activity, effectiveness, and safety of UBX1325, the potential for UNITY to successfully commence and complete clinical studies of UBX1325 for DME, AMD, and other ophthalmologic diseases, the expected timing of results of our studies of UBX1325, the timing of the expected commencement, progression, and conclusion of our studies including those of UBX1325, and UNITY’s expectations regarding the sufficiency of its cash runway. These statements involve substantial known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements, including the risk that the COVID-19 worldwide pandemic may continue to negatively impact the development of preclinical and clinical drug candidates, including delaying or disrupting the enrollment of patients in clinical trials, risks relating to the uncertainties inherent in the drug development process, and risks relating to UNITY’s understanding of senescence biology. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions, and expectations disclosed in the forward-looking statements we make. The forward-looking statements in this presentation and the accompanying oral commentary represent our views as of the date of this presentation and oral commentary. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this presentation. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of UNITY in general, see UNITY’s most recent Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, filed with the Securities and Exchange Commission on May 11, 2021, as well as other documents that may be filed by UNITY from time to time with the Securities and Exchange Commission. This presentation concerns drug candidates that are under clinical investigation and which have not yet been approved for marketing by the U.S. Food and Drug Administration. They are currently limited by Federal law to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated.
3 PATIENT 232-0009 DME, 5 µg UBX1325 "The imaging data demonstrating structural improvements in the retina are compelling at this stage of clinical development and represent defined endpoints for disease improvement…" Jeffrey Heier, M.D. Director of the Vitreoretinal Service and Retina Research, Ophthalmic Consultants of Boston UBX1325 PROVIDES AN OPPORTUNITY FOR A TRANSFORMATIVE, DISEASE-MODIFYING THERAPY FOR DME AND nAMD PATIENTS
4 UBX1325 PROVIDES AN OPPORTUNITY FOR A TRANSFORMATIVE, DISEASE-MODIFYING THERAPY FOR DME AND nAMD PATIENTS Built on UNITY’s Senescent Cell Biology Platform UBX1325, the first senolytic drug being explored in eye disease, had a favorable safety and tolerability profile Initial efficacy data show rapid improvements in vision and retinal structure in DME and nAMD patients after a single dose Could provide disease-modification by reversing pathophysiology and restoring tissue health Novel mechanism of action could benefit both treatment-naïve patients as well as poor anti-VEGF responders Data support senolytic therapeutic hypothesis Mechanism has broad implication for diseases of aging 4 Phase 1 Data Highlights Implications for Addressing Unmet Need
NEUROLOGY: Alzheimer’s, FTD, PSP (and other Tauopathies), ALS, Cognitive Disorders OPHTHALMOLOGY: DME, AMD, Diabetic Retinopathy UNITY IS DEVELOPING TRANSFORMATIVE MEDICINES TO SLOW, HALT, OR REVERSE DISEASES OF AGING 5 Targeting cellular senescence and aging-related biology
SENESCENT CELLS AFFECT THE TISSUE MICRO-ENVIRONMENT TO DRIVE DISEASE PROGRESSION 6 Senescence-Associated Secretory Phenotype1 INFLAMMATORY FACTORS (e.g., TNF-α, IL-1α, IL-1β, IL-6, CCL11) PRO-FIBROTIC FACTORS (e.g., TGFβ1, TIMP-1, MCP-1, MMPs) GROWTH FACTORS (e.g., VEGF-A, PDGF, IL-8, PAI-1) CELLULAR STRESS PROLIFERATING CELLS CELL CYCLE ARREST 1Coppe et al. Annu Rev Pathol 2010;5:99-118. INITIATION OF SENESCENCE
UNITY IS DEVELOPING SENOLYTIC MEDICINES TO ELIMINATE SENESCENT CELLS TO RESTORE TISSUE HEALTH 7 Functional Cell Senescent Cell (SnC) Cytokines, chemokines & matrix remodeling factors (SASP) Macrophage CD4+ T lymphocyte Fibroblast Target Senescent Cells and neutralize SASP factors to eliminate root cause of disease progression
THERAPEUTIC HYPOTHESIS: ELIMINATION OF VASCULAR SENESCENT CELLS BY UBX1325 SHOULD RE-ESTABLISH BARRIER FUNCTION AND REVERSE DISEASE PROGRESSION IN DME AND nAMD PATIENTS UBX1325 8
UBX1325 TARGETS A NODE UPSTREAM OF ANTI-VEGF THERAPIES 9 UBX1325 Modified from Urias et al. Vision Res 2017;139:221-227 and Das et al. Ophthalmology 2015;122:1375-1394. Inflammatory Microenvironment PDGF INTEGRINS BFGF Ang2 HGF MMP IL1�� IL6 KKS ICAM-1 IL1�� VEGF MCP-1
UBX1325 PROVIDES AN OPPORTUNITY FOR A TRANSFORMATIVE BEST-IN-DISEASE THERAPY 10 UBX1325 Rapid effect with greater efficacy and durability than SoC Aspirational Treatment Benefits for DME and nAMD Patients Potential for disease modification Novel MOA and favorable pharmacology Able to use in combination with anti-VEGF agents Potential for improvement of retinal/choroidal blood flow Able to reduce ischemic regions of the retina
UBX 1325 Phase 1 Trial Design and Summary Data Initial 12 Patients in SAD Study 11 Data presented are preliminary reads prior to fully monitoring, validating, and locking the data sets.
UBX1325 CLINICAL PROGRAM 2020 2021 2022 Long-Term Follow-up Phase 2a DME Study First patient dosed June 2021 SAFETY & TOLERABILITY DOSE, EFFICACY & DURABILITY 12 Single Injection of UBX1325 24-week Follow-up Phase 1 SAD Study - up to 10 µg Phase 2a nAMD Study* 2023+ *Study under consideration
STUDY UBX1325-01: SINGLE ASCENDING DOSE SAFETY STUDY IN PATIENTS WITH ADVANCED DME OR nAMD 13 Cohort 1 0.5 µg/eye n=3 Cohort 2 1.0 µg/eye n=3 Cohort 4 5.0 µg/eye n=3 Cohort 5 10 µg/eye n=3 Study Population Advanced DME or nAMD with BCVA of 20/80 (55 ETDRS letters) or worse in the first 2 cohorts; 20/40 (70 ETDRS letters) or worse in later cohorts Patients for whom anti-VEGF therapy was no longer considered beneficial Patients had received neither an anti-VEGF agent nor a corticosteroid in the 3 months preceding enrollment DME patients had ≥350 µm of fluid; nAMD patient had presence of either sub- or intra-retinal fluid
EXECUTIVE SUMMARY: UBX1325 PHASE 1 SAD STUDY 14
UBX1325 WAS WELL-TOLERATED THROUGH ALL DOSES 15 Safety and Tolerability acceptable to advance to additional clinical studies with UBX1325 in ocular diseases * Same patients, not treatment-related
BY 4 WEEKS, PATIENTS SHOW RAPID INCREASE IN BCVA AMONGST HIGH DOSE COHORTS AFTER SINGLE DOSE UBX1325 16
BY 4 WEEKS, PATIENTS SHOW RAPID INCREASE IN BCVA AMONGST HIGH DOSE COHORTS AFTER SINGLE DOSE UBX1325 17 Not a head-to-head trial.
BY 4 WEEKS, MAJORITY OF PATIENTS SHOW DECREASE IN CST AMONGST HIGH DOSE COHORTS AFTER SINGLE DOSE UBX1325 18
Examples of Imaging Data 19 Normal Optical Coherence Tomograph (OCT)
DME PATIENT 232-0009, 5 µg BCVA IMPROVED, CST DECREASED 20 Baseline Week 4 CST REDUCED Registered Image Registered Image
DME PATIENT 232-0008, 5 µg BCVA IMPROVED, CST DECREASED 21 Baseline Week 4 Central Cyst Hyperreflective Foci Registered Image Registered Image
nAMD PATIENT 230-0007: 1 µg BCVA IMPROVED, CST AND SRF REDUCED 22 Baseline Week 8 Hyperreflective foci
nAMD PATIENT 229-0012: 5 µg BCVA IMPROVED, CST AND SRF REDUCED 23 Baseline Week 4 subretinal fluid Registered Image Registered Image
EXECUTIVE SUMMARY: UBX1325 PHASE 1 SAD STUDY 24
25 PATIENT 232-0009 DME, 5 µg UBX1325 "The imaging data demonstrating structural improvements in the retina are compelling at this stage of clinical development and represent defined endpoints for disease improvement…" Jeffrey Heier, M.D. Director of the Vitreoretinal Service and Retina Research, Ophthalmic Consultants of Boston UBX1325 PROVIDES AN OPPORTUNITY FOR A TRANSFORMATIVE, DISEASE-MODIFYING THERAPY FOR DME AND nAMD PATIENTS
26 UBX1325 Ph1 Data Conference Call Q&A July 6th, 2021 Anirvan Ghosh, CEO Jamie Dananberg, CMO Lynne Sullivan, CFO