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
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 8.01 Other Events.
On November 1, 2022, Unity Biotechnology, Inc. (“UNITY” or the “Company”) announced positive 24-week data from its Phase 2 BEHOLD study of UBX1325 in patients with diabetic macular edema (DME). The Company will host a conference call today, Tuesday, November 1, 2022, at 8:00 a.m., Eastern Time, to discuss the data results.
A copy of the press release and the presentation that will be referenced during the conference call are filed as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report on Form 8-K and are incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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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 November 1, 2022 |
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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, 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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November 1, 2022 |
By: |
/s/ Anirvan Ghosh |
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Anirvan Ghosh, Ph.D. |
Exhibit 99.1
UNITY Biotechnology Announces Positive 24-Week Data from Phase 2 BEHOLD Study of UBX1325 in Patients with Diabetic Macular Edema
A single injection of UBX1325 led to a statistically significant and clinically relevant improvement in Best Corrected Visual Acuity (BCVA) of 7.6 ETDRS letters at 24 weeks compared to sham treatment
UBX1325 maintained stabilization of retinal structure, as measured by central subfield thickness (CST) at 24 weeks, as compared to worsening from baseline in sham-treated patients
The proportion of rescue-free patients in the UBX1325-treated arm was 59.4% at 6 months after a single injection, as compared to only 37.5% in the sham-treated arm
UNITY to host investor call with retinal expert Arshad M. Khanani, M.D., M.A., FASRS, today,
November 1, at 8:00 a.m. ET
SOUTH SAN FRANCISCO, Calif., November 1, 2022 – UNITY Biotechnology, Inc. (“UNITY”) [Nasdaq: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced that the key safety and efficacy endpoints were met at 24 weeks in the Phase 2 BEHOLD study of UBX1325 in patients with diabetic macular edema (DME). The Company intends to initiate a pivotal study in DME in the second half of 2023.
At 24 weeks after a single dose of UBX1325, the mean change in BCVA of UBX1325-treated subjects was an increase of +6.2 ETDRS letters, representing an improvement of +7.6 ETDRS letters compared to sham-treated subjects from baseline (p = 0.0084). In addition, patients treated with UBX1325 maintained CST compared to sham-treated patients who demonstrated worsening of CST (i.e., increased retinal thickness) through 24 weeks. Of patients treated with UBX1325, 59.4% did not require anti-VEGF standard of care through 6 months, as compared to only 37.5% of sham-treated patients.
“It is remarkable to see such clinically meaningful and sustained improvements in vision after a single injection of UBX1325 in patients who had reached a therapeutic plateau with anti-VEGF treatment,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “In today’s treatment paradigm for DME, most patients require frequent injections – and still a large proportion of patients with the current standard of care have residual visual deficits. Based on the results of this study we believe UBX1325 could lead to significant vision gain while reducing treatment burden for patients. The durable effect we’ve now observed through 6 months following just a single injection of UBX1325 suggests it could represent a longer-lasting, disease-modifying treatment option for patients.”
Patients enrolled in BEHOLD had been on anti-VEGF treatment for at least 6 months prior to enrollment into the study (mean injection frequency of 4 in the preceding 6 months), with the last anti-VEGF injection occurring 3 – 6 weeks prior to randomization.
Evidence of favorable safety, visual acuity improvement, and structural stability in a difficult-to-treat patient population at 24 weeks:
“A 7.6-letter gain in BCVA from baseline in UBX1325-treated patients who had visual deficits and retinal fluid despite being on anti-VEGF treatment is a clinically meaningful and impressive outcome,” said Arshad M. Khanani, M.D., M.A., Director of Clinical Research at Sierra Eye Associates. “A potential treatment with a novel mechanism of action that provides significant and durable gain in vision would be of great value to patients with DME.”
Jamie Dananberg, M.D., chief medical officer of UNITY added, “We believe we have altered the disease trajectory of patients treated with UBX1325, as evidenced by the 24-week results. Observing significantly greater letter gains and stabilization of retinal structure compared to the sham arm after a single injection of UBX1325 is encouraging and speaks to the potential of disease modification with a senolytic treatment. We look forward to further evaluating the durability of treatment effect through 48 weeks with our long-term extension of the BEHOLD study.”
Upcoming Clinical Milestones for UBX1325
Conference Call at 8:00 a.m. ET Today
UNITY will host a video conference call and webcast for investors and analysts today at 8:00 a.m. ET to discuss the most recent UBX1325 clinical data. Dr. Arshad M. Khanani, M.D., M.A., FASRS, Director of Clinical Research at Sierra Eye Associates, as well as members of the UNITY senior management team, will lead the discussion on the 24-week BEHOLD study results. 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. 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 the BEHOLD Study
The proof-of-concept Phase 2 BEHOLD study is a multi-center, randomized, double-masked, sham-controlled study designed to evaluate the safety, tolerability, efficacy and durability of a single 10 mcg dose of UBX1325 in patients with DME evaluated though 24 weeks. The study enrolled 65 patients being actively treated with anti-VEGF who had a visual acuity deficit (73 ETDRS letters, approximately 20/40, or worse) and residual retinal fluid (CST ≥300 microns). Patients have the option of continuing in the long-term extension portion of the study through 48-weeks. To date, a majority of patients have opted to remain in the study. More information about the study is available here (NCT04857996).
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 (DR) 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 a Phase 1 clinical study in advanced wet AMD and DME, UBX1325 showed a favorable safety profile and improvements in visual acuity sustained through 24 weeks following a single intravitreal injection. 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 DME, AMD, and DR.
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 and nature of results of our studies of UBX1325 including BEHOLD and ENVISION, including the risk that interim results of our clinical studies may not be indicative of future results, 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 recently filed Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, filed with the Securities and Exchange Commission on August 12, 2022, as well as other documents that may be filed by UNITY from time to time with the Securities and Exchange Commission.
Media Contact
Evoke Canale
Katherine Smith
Katherine.Smith@evokegroup.com
Investor Contact
LifeSci Advisors, LLC
Joyce Allaire
jallaire@lifesciadvisors.com
Arshad M. Khanani MD, MA, FASRS Director of Clinical Research at Sierra Eye Associates Anirvan Ghosh, CEO Jamie Dananberg, CMO Lynne Sullivan, CFO UBX1325 Phase 2 BEHOLD DME Study 24 Week Data 01-Nov-2022 Exhibit 99.2
Special Note Regarding Forward-Looking Statements This presentation and the accompanying oral commentary contain forward-looking statements including statements related to Unity Biotechnology Inc.’s (“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 potential for UNITY to successfully commence and complete clinical studies of UBX1325 for DME, AMD, and other ophthalmologic diseases, the expected timing of enrollment and results of the clinical trials in 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, including the risk that interim results of our clinical studies may not be indicative of future results, 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 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 June 30, 2022, filed with the Securities and Exchange Commission on August 12, 2022, 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 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. This presentation does not constitute an offer or invitation for the sale or purchase of securities and has been prepared solely for informational purposes. 01-Nov-2022
01-Nov-2022 UBX1325 Led to a Statistically Significant and Clinically Relevant Improvement in Visual Acuity in Patients with Diabetic Macular Edema Built on UNITY’s Senescent Cell Biology Platform A single dose of UBX1325 led to a statistically significant and clinically relevant improvement in vision as measured by BCVA out to 24 weeks in DME patients Retinal structure was maintained through 24 weeks in UBX1325-treated patients, compared to worsening in sham-treated patients Approximately 60% of UBX1325-treated patients did not require anti-VEGF rescue through 24 weeks compared to only ~38% of sham-treated patients UBX1325, the first senolytic drug being explored in eye disease, had a favorable safety and tolerability profile, with no evidence of intra-ocular inflammation This novel mechanism of action could benefit patients as monotherapy or in combination with anti-VEGF agents Preclinical mechanism of action and efficacy data support senolytic therapeutic hypothesis Mechanism has broad implication for diseases of aging Phase 2 BEHOLD Study Data Highlights
01-Nov-2022 UNITY Is Developing Senolytic Medicines to Eliminate Senescent Cells to Restore Vascular Health and Improve Vision DME: Increased senescence burden Retinal vasculature affected Blood retinal barrier (BRB) Breakdown Loss of vision DME treated with Senolytic intended results: Senescent cells removed Retinal vasculature restored Improvement in vision BRB Breakdown Repaired Retina UNITY illustration. Diabetic Macular Edema
UBX1325 Vessel remodeling Diabetic blood vessel Repaired blood vessel - UBX1325 selectively triggers cell death of Sn ECs - UBX1325 reduces retinal inflammation and vascular leakage Senescent (Sn) ECs accumulate in diabetic retinas in areas of disease activity Preclinical data predicts progressive disease modification through vascular remodeling 01-Nov-2022 Proposed Mechanism of Action for UBX1325
01-Nov-2022 UBX1325 Clinical Program Overview Safety & Tolerability Safety & Efficacy 2020 2021 2022 2023 Phase 1 ENVISION Phase 2 nAMD Study BEHOLD Phase 2 DME Study SAD 24-Week Follow-up nAMD 24 Week Follow-up SAD Study - up to 10 µg 4Q ‘21 1H ‘22 2H ‘22 Long-Term Extension DME Proof of Concept Study (First-Patient-In June 2021) Part B nAMD Proof of Concept Study (FPI April 2022) 12wk, 24wk nAMD cohort data 12/18 wk efficacy data 8/16 wk efficacy data 24wk SAD data 24 wk efficacy data 24 wk efficacy data 48 wk efficacy data 48 wk efficacy data 1H ‘23 2H ‘23
UBX1325 Phase 2 BEHOLD Study Historic Data on DME Patients treated with Standard of Care 01-Nov-2022
VISTA BLA 125387 Suppl 48, 25 Mar 2015 01-Nov-2022 Context for 24wk DME Data: After Anti-VEGF Effect Has Plateaued, Patients Gain Approximately 1 Letter in Subsequent 6 Months on Aflibercept Treatment
UBX1325 Phase 2 BEHOLD Study 24-Week Data in Patients With DME 01-Nov-2022 9
01-Nov-2022 BEHOLD Study Design, Patient Population, and Endpoints Individuals with Diabetic Macular Edema (with moderate diabetic proliferative retinopathy or better), residual retinal fluid (≥300 µm) and visual acuity deficit (73 ETDRS letters or worse) despite having received repeated anti-VEGF treatments (≥2 injections over last 6 months, last 3-6 weeks prior to randomization). Most subjects had 3 or more injections in preceding 6-month period. Patient Population * * Safety and tolerability BCVA change from baseline Durability of response Sub- and intra-retinal fluid, CST changes Proportion of UBX1325 patients requiring 2 or more rescue treatments Changes in choroidal blood flow (OCT-A) Endpoints UBX Sham Total Total Enrolled 32 33 65 Withdrawal, out-of-window visit at Wk24, lost to f/u 4 2 6 24-week analysis set 28 31 59
01-Nov-2022 BEHOLD: 24-Week BCVA Change from Baseline† Met Pre-specified Criteria for Proof of Concept Sham UBX1325 Difference P-Value Week 18 1.7 5.9 4.3 0.0943* Week 24 -1.4 6.2 7.6 0.0084** ** * UBX1325 Led To A Sustained Improvement In BCVA Through 24 Weeks † MMRM Analysis
01-Nov-2022 BEHOLD: 24-Week BCVA Change from Baseline† Including Post-Rescue Data Sham UBX1325 Difference P-Value Week 18 2.6 5.6 3.0 0.1160* Week 24 1.2 6.4 5.2 0.0068** UBX1325 with As-Needed anti-VEGF Rescue Outperformed Sham with As-Needed Rescue Through 24 Weeks†† ** * † MMRM Analysis †† More rescues in Sham vs. UBX arms
01-Nov-2022 Greater Proportion of Patients in UBX1325 Arm Have Larger Visual Acuity Gains Compared to Sham at 24 Weeks Gains in BCVA without Rescue Gains in BCVA w/ Rescue
01-Nov-2022 BEHOLD: 24-Week CST Change from Baseline† Met Pre-specified Criteria for Proof of Concept Sham UBX1325 Difference P-Value Week 18 60.3 8.2 -52.1 0.0278* Week 24 34.6 -5.4 -40.0 0.1244** ** * UBX1325 Stabilized the Retina Compared to Sham-Treatment † MMRM Analysis
Adding anti-VEGF rescue data improved CST in sham arm but not in UBX1325 arm†† LS Mean Sham UBX1325 Difference P-Value Week 24 2.7 -4.2 -6.9 0.7522 01-Nov-2022 BEHOLD: 24-Week CST Change from Baseline† Including Post-rescue Data Sham UBX1325 Difference P-Value Week 18 26.0 8.7 -17.3 0.4179 Week 24 2.7 -4.2 -6.9 0.7522 † MMRM Analysis †† More rescues in Sham vs. UBX arms
In BEHOLD, 4 subgroup factors with 8 total subgroups (2 each) were evaluated based on baseline values for: BCVA (≤60 vs. >60 ETDRS letters) CST (≤400 vs. >400µm) DRSS Score (<47 vs. ≥47) A1c (≤7 vs. >7%) For the response of BCVA, there was a numeric advantage in all 8 subgroups for UBX1325-treated patients For the response of CST, there was a numeric advantage in all 8 subgroups for UBX1325-treated patients Summary of Subgroup Analyses at 24 Weeks 01-Nov-2022
01-Nov-2022 Majority of Patients on UBX1325 Were Rescue-free for 6 Months Rescue Eligibility Criteria (Either Triggers Rescue): Increase in CST of +75µm from the lowest value (trough) Decrease in BCVA of -10 ETDRS letters from the highest value (peak) p = 0.0664 No rescue: UBX vs Sham
01-Nov-2022 Summary of Treatment Emergent Adverse Events Sham (%) (N = 33) UBX1325 10 µg (%) (N = 32) Overall (%) (N = 65) Subjects with at least one TEAE 28 (84.8) 24 (75.0) 52 (80.0) Related TEAE 3 (9.1) 6 (18.8) 9 (13.8) Grade ≥3 TEAE 4 (12.1) 3 (9.4) 7 (10.8) Serious TEAE 3 (9.1)* 4 (12.5)* 7 (10.8) Ocular TEAE for Study Eye 23 (69.7) 19 (59.4) 42 (64.6) Treatment-related Ocular TEAE for Study Eye 3 (9.1)** 6 (18.8)** 9 (13.8) TEAE leading to death 0 0 0 Intraocular inflammation, endophthalmitis, retinal artery occlusion, or vasculitis 0 0 0 * Unrelated or likely unrelated to treatment ** 2/3 Sham and 5/6 UBX most likely attributable to procedure: Conjunctival hemorrhage, eye irritation, conjunctival hyperemia All mild – moderate, resolved without further intervention
Examples of Imaging Data Normal Optical Coherence Tomograph (OCT) 01-Nov-2022
01-Nov-2022 PATIENT A Weeks Post Single Injection of UBX1325 BL 4 8 12 Weeks Post Single Injection of UBX1325 18 24 CFBL Week 12 Week 18 Week 24 BCVA (ETDRS letters) +19 +9 +16 CST (µm) -99 -101 -107 Tx History: aflibercept x5/6 mo. w/ last 4 weeks prior to randomization 68 ETDRS Letters 423 µm 84 ETDRS Letters 316 µm 87 ETDRS Letters 324 µm 77 ETDRS Letters 322 µm 80 ETDRS Letters 411 µm 82 ETDRS Letters 361 µm
01-Nov-2022 PATIENT B Weeks Post Single Injection of UBX1325 BL 4 8 12 Weeks Post Single Injection of UBX1325 18 24 CFBL Week 12 Week 18 Week 24 BCVA (ETDRS letters) +8 +11 +10 CST (µm) -304 -336 -194 Tx History: bevacizumab x4 doses/6 mo. w/ last 3 wks prior to randomization 35 ETDRS Letters 584 µm 45 ETDRS Letters 390 µm 43 ETDRS Letters 280 µm 46 ETDRS Letters 248 µm 31 ETDRS Letters 518 µm 41 ETDRS Letters 268 µm
01-Nov-2022 A Single Injection of UBX1325 Provided Evidence of a Senolytic Agent Improving Visual Acuity in Patients with Diabetic Macular Edema Was well tolerated with a favorable safety profile and no intraocular inflammation Improved BCVA that was durable for a minimum of 6 months after one dose Maintained retinal structure vs. sham-treated subjects Allowed ~60% of patients to avoid anti-VEGF treatment for at least 6 months @Vicki Can we make the this slide a little more punchy/less flat? UBX1325 UBX1325 Provides an Opportunity for a Transformative First-in-Class and Best-in-Disease Therapy In the BEHOLD Study, UBX1325:
Clinical Development Plan
01-Nov-2022 Key Highlights from Phase 2 BEHOLD DME Study 24-Week data underscore the therapeutic potential of UBX1325 Visual Acuity Improvement Control of Macular Edema Impact on Retinal Structure
2022 2023 2024 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A S O N D LPI LPLV LPLV DME 1325-02 TLR DBL TLR DBL 1325-01 Ph1 SAD 12/18w efficacy analysis AMD 1325-03 LPI 16w efficacy analysis 24w follow-up DME Pivotal Study* 48w follow-up TLR DBL 24w readout 1325-02 DME Ph2 BEHOLD Study 1325-03 AMD Ph2 ENVISION Study FPI Long-term Extension 48w readout LPLV *intended for 2H2023; readout 2025 UBX1325 Program Overview and Data Readouts 2022-24 Part B 01-Nov-2022
Concluding Remarks 01-Nov-2022
Potential to meaningfully change the treatment paradigm 01-Nov-2022 UBX1325 Has a Differentiated Profile With Best-In-Disease Potential Safety and Efficacy Profile Current standard of care (Aflibercept) aVEGF/Ang2 bispecific (Faricimab) UBX1325 Favorable safety and PK profile Strong efficacy signal in broad patient population including sub-optimal anti-VEGF responders X X >50% patients achieve 6-month treatment free interval after single injection X X Reduction of ischemic regions of the retina and potential for disease modification X X supported by preclinical data supported by clinical data
Q&A 28
Market Snapshot $64.5 million cash, cash equivalents and marketable securities as of June 30, 2022. Completed underwritten offering in August raising $41.8 million in net proceeds Focused capital allocation to extend cash runway into 2024, funding UBX1325 Phase 2 proof-of-concept studies and 48-week long-term extension Financials 29 01-Nov-2022
Positioning of UBX1325 in Current DME Therapeutic Landscape ** ~50% of patients on anti-VEGF do not achieve 20/40 vision after 2 years of treatment (Shimura M, et al. Br J Ophthalmol 2020;104:1209–1215) Anti-VEGF non- and sub-responders (residual fluid and visual deficits) Switch to anti-VEGF+UBX1325 to maximize benefit from dual mechanism Switch UBX1325 for greater efficacy above anti-VEGF plateau effect Patients achieving worse than 20/40 vision despite anti-VEGF treatment, represent a significant opportunity for UBX1325** Well-treated with anti-VEGF (injections every 4-8 weeks) Switch to UBX1325 to reduce treatment burden and potential for disease modification 01-Nov-2022