UNITY Biotechnology, Inc. Reports Second Quarter 2022 Financial Results and Business Updates
- Announced Positive Data in Phase 2 BEHOLD Study of UBX1325 in Patients with Diabetic Macular Edema; single injection in subjects led to statistically significant and clinically meaningful improvement in BCVA and CST with favorable safety profile at 12 and 18 weeks -
- Near-Term Milestones include 24-week Data in BEHOLD and 16-week Data in Phase 2 ENVISION Study of UBX1325 in Patients with Wet Age-Related Macular Degeneration by Year-End -
- Tie2/VEGF Bispecific Program Achieved Advanced Candidate Nomination -
- As of
“We are thrilled with the recent data announced in our BEHOLD Study in patients with DME and are grateful for the support and enthusiasm from our physician community and other stakeholders,” said
As reported on
Evidence of favorable safety, vision improvement, and structural stability in a difficult-to-treat patient population:
Overall Safety
UBX1325 demonstrated a favorable safety and tolerability profile with no cases of intraocular inflammation, retinal vein occlusion, endophthalmitis, or vasculitis.
At 12 weeks (primary analysis set of 65 patients)
- Patients enrolled in BEHOLD were receiving regular anti-VEGF treatment prior to enrollment into the study with the last anti-VEGF injection occurring 3 – 6 weeks prior to randomization
- Patients treated with UBX1325 had a mean improvement in BCVA of +4.7 ETDRS letters compared to +1.3 ETDRS letters in sham-treated patients (p=0.1148)
- Patients treated with UBX1325 had a mean change in CST of -1.4 microns from baseline compared to +40.3 microns in sham-treated patients (p=0.0747)
At 18 weeks (primary analysis set of 54 patients)
- Patients treated with UBX1325 had a mean improvement in BCVA of +6.1 ETDRS letters compared to +1.1 EDTRS letters in sham-treated patients (p=0.0368)
- Patients treated with UBX1325 had a mean change from baseline in CST of +3.2 microns compared to +53.5 microns in sham-treated patients (p=0.0719)
Based on pre-defined proof-of-concept criteria of alpha=0.15, the study demonstrated a statistically significant treatment effect for both BCVA and CST at both timepoints.
In addition, the Company’s Tie2/VEGF bispecific drug development candidate obtained the preclinical data to support its selection as an advanced candidate. Tie2 is a receptor tyrosine kinase that is implicated in regulating barrier function in blood vessels of the eye, which are affected in several prevalent eye diseases. The Tie2/VEGF preclinical program targeting both Tie2 and VEGF is designed to neutralize VEGF and activate Tie2, two major pathways involved in retinal disease.
Upcoming Milestones
- UBX1325 24-week safety and efficacy data from BEHOLD, the Phase 2 DME clinical trial (UBX1325-02 Study) before year-end 2022
- UBX1325 16-week safety and efficacy data from ENVISION, the Phase 2 wAMD clinical trial (UBX1325-03 Study) expected before year-end 2022
- Tie2/VEGF bispecific preclinical data to support selection of development candidate by year-end 2022
Second Quarter Financial Results
Cash, cash equivalents and marketable securities totaled
Operating loss for the three months ended
Research and development expenses decreased by
General and administrative expenses decreased by
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, 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, 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 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.
Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except share and per share amounts)
| Three Months Ended | Six Months Ended | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Licensing revenue - related party | 236 | — | $ | 236 | — | |||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 7,553 | 11,016 | $ | 20,014 | $ | 19,733 | ||||||||||
| General and administrative | 4,941 | 5,980 | 10,747 | 12,206 | ||||||||||||
| Total operating expenses | 12,494 | 16,996 | 30,761 | 31,939 | ||||||||||||
| Loss from operations | (12,258 | ) | (16,996 | ) | (30,525 | ) | (31,939 | ) | ||||||||
| Interest income | 58 | 26 | 87 | 62 | ||||||||||||
| Interest expense | (894 | ) | (784 | ) | (1,702 | ) | (1,559 | ) | ||||||||
| Other income (expense), net | (43 | ) | (72 | ) | 88 | (146 | ) | |||||||||
| Net loss | (13,137 | ) | (17,826 | ) | (32,052 | ) | (33,582 | ) | ||||||||
| Other comprehensive (loss) gain | ||||||||||||||||
| Unrealized loss on marketable debt securities | (11 | ) | (10 | ) | (143 | ) | — | |||||||||
| Comprehensive loss | $ | (13,148 | ) | $ | (17,836 | ) | $ | (32,195 | ) | $ | (33,582 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.19 | ) | $ | (0.32 | ) | $ | (0.47 | ) | $ | (0.62 | ) | ||||
| Weighted-average number of shares used in computing net loss per share, basic and diluted | 69,247,818 | 54,859,727 | 68,392,934 | 54,516,445 | ||||||||||||
Condensed Balance Sheets
(In thousands)
| 2022 | 2021 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 19,442 | $ | 32,905 | ||||
| Short-term marketable securities | 45,065 | 55,170 | ||||||
| Prepaid expenses and other current assets | 2,765 | 1,879 | ||||||
| Restricted cash | 550 | 550 | ||||||
| Total current assets | 67,822 | 90,504 | ||||||
| Property and equipment, net | 8,697 | 9,942 | ||||||
| Operating lease right-of-use assets | 20,116 | 21,286 | ||||||
| Long-term marketable securities | — | 1,993 | ||||||
| Long-term restricted cash | 896 | 896 | ||||||
| Other long-term assets | 62 | 91 | ||||||
| Total assets | $ | 97,593 | $ | 124,712 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,437 | $ | 1,985 | ||||
| Accrued compensation | 3,291 | 4,028 | ||||||
| Accrued and other current liabilities | 4,604 | 6,370 | ||||||
| Deferred revenue | — | 216 | ||||||
| Derivative liability related to debt | — | 963 | ||||||
| Current portion of long-term debt | 7,087 | 3,055 | ||||||
| Total current liabilities | 16,419 | 16,617 | ||||||
| Operating lease liability, net of current portion | 28,573 | 30,094 | ||||||
| Long-term debt, net | 12,670 | 18,409 | ||||||
| Other long-term liabilities | — | 23 | ||||||
| Total liabilities | 57,662 | 65,143 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock | 7 | 6 | ||||||
| Additional paid-in capital | 472,187 | 459,631 | ||||||
| Accumulated other comprehensive loss | (187 | ) | (44 | ) | ||||
| Accumulated deficit | (432,076 | ) | (400,024 | ) | ||||
| Total stockholders’ equity | 39,931 | 59,569 | ||||||
| Total liabilities and stockholders’ equity | $ | 97,593 | $ | 124,712 | ||||
Media Contact
katherine.smith@evokegroup.com
Investor Contact
jallaire@lifesciadvisors.com
Source: Unity Biotechnology, Inc.