UNITY Biotechnology, Inc. (UNITY) [NASDAQ:UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today reported financial results for the second quarter ended June 30, 2022.

“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 Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “The sustained and significant improvement in visual acuity after a single injection of UBX1325 is very impressive, and , if approved, could provide an attractive treatment option for patients who currently can only hope to maintain their vision at the cost of frequent injections with current standard of care. We look forward to sharing our 24-week data in BEHOLD as we continue to investigate UBX1325, along with 16-week data in ENVISION, our study in wet age-related macular degeneration.”

As reported on August 12, 2022, the Company announced positive 12- and 18-week data in its Phase 2 BEHOLD Study of UBX1325 in Patients with Diabetic Macular Edema:

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 $64.5 million as of June 30, 2022, compared with $79.2 million as of March 31, 2022. UNITY believes that current cash, cash equivalents, and marketable securities are sufficient to fund operations through the first quarter of 2023.

Operating loss for the three months ended June 30, 2022, was $12.3 million compared to $17.0 million for the three months ended June 30, 2021. Cash used in operations during the first and second quarters of 2022 was $29.8 million compared to $28.5 million for the first and second quarters of 2021.

Research and development expenses decreased by $3.5 million, to $7.5 million for the three months ended June 30, 2022 from $11.0 million for the three months ended June 30, 2021. The decrease was primarily due to decreases of $1.4 million in direct research and development expenses mainly due to the $2.0 million milestone payment to Ascentage Pharma during the three months ended June 30, 2021, $0.7 million in personnel costs due to reduction in force, $0.5 million in laboratory supplies and $0.9 million in facilities-related and other operating costs due to allocation to general and administrative expenses of net expenses on Brisbane and East Grand facilities which have been subleased.

General and administrative expenses decreased by $1.0 million, to $5.0 million for the three months ended June 30, 2022 from $6.0 million for the three months ended June 30, 2021. The decrease was primarily due to decreases of $0.7 million in personnel costs mainly due to reduction in force, $0.2 million in professional fees and $0.1 million in facilities-related and other operating costs.