UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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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.
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Item 2.02 |
Results of Operations and Financial Condition. |
On August 12, 2022, Unity Biotechnology, Inc. (the “Company”) announced its financial results for the second quarter ended June 30, 2022 and provided business updates. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K, including the attached Exhibit 99.1, is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
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Item 9.01 |
Financial Statements and Exhibits. |
Reference is made to the Exhibit Index attached hereto.
EXHIBIT INDEX
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Exhibit No. |
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Description |
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99.1 |
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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: August 12, 2022 |
By: |
/s/ Anirvan Ghosh |
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Anirvan Ghosh, Ph.D. |
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Chief Executive Officer |
Exhibit 99.1
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 June 30, 2022, UNITY had approximately $64.5 million in cash, cash equivalents and marketable securities, providing runway through Q1 2023 -
SOUTH SAN FRANCISCO, Calif., August 12, 2022 (GLOBE NEWSWIRE) -- 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)
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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 |
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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) |
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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)
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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) |
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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
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UBX1325 24-week safety and efficacy data from BEHOLD, the Phase 2 DME clinical trial (UBX1325-02 Study) before year-end 2022 |
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UBX1325 16-week safety and efficacy data from ENVISION, the Phase 2 wAMD clinical trial (UBX1325-03 Study) expected before year-end 2022 |
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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.
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.
Unity Biotechnology, Inc.
Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except share and per share amounts)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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Licensing revenue - related party |
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236 |
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— |
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$ |
236 |
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— |
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Operating expenses: |
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Research and development |
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7,553 |
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11,016 |
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$ |
20,014 |
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$ |
19,733 |
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General and administrative |
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4,941 |
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5,980 |
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10,747 |
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12,206 |
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Total operating expenses |
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12,494 |
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16,996 |
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30,761 |
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31,939 |
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Loss from operations |
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(12,258 |
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(16,996 |
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(30,525 |
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(31,939 |
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Interest income |
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58 |
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26 |
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87 |
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62 |
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Interest expense |
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(894 |
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(784 |
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(1,702 |
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(1,559 |
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Other income (expense), net |
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(43 |
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(72 |
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88 |
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(146 |
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Net loss |
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(13,137 |
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(17,826 |
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(32,052 |
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(33,582 |
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Other comprehensive (loss) gain |
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Unrealized loss on marketable debt securities |
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(11 |
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(10 |
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(143 |
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— |
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Comprehensive loss |
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$ |
(13,148 |
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$ |
(17,836 |
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$ |
(32,195 |
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$ |
(33,582 |
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Net loss per share, basic and diluted |
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$ |
(0.19 |
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$ |
(0.32 |
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$ |
(0.47 |
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$ |
(0.62 |
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Weighted-average number of shares used in computing net loss per share, basic and diluted |
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69,247,818 |
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54,859,727 |
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68,392,934 |
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54,516,445 |
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Unity Biotechnology, Inc.
Condensed Balance Sheets
(In thousands)
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June 30, |
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December 31, |
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2022 |
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2021 |
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(Unaudited) |
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Assets |
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Current Assets: |
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Cash and cash equivalents |
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$ |
19,442 |
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$ |
32,905 |
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Short-term marketable securities |
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45,065 |
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55,170 |
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Prepaid expenses and other current assets |
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2,765 |
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1,879 |
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Restricted cash |
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550 |
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550 |
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Total current assets |
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67,822 |
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90,504 |
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Property and equipment, net |
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8,697 |
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9,942 |
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Operating lease right-of-use assets |
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20,116 |
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21,286 |
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Long-term marketable securities |
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— |
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1,993 |
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Long-term restricted cash |
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896 |
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896 |
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Other long-term assets |
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62 |
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91 |
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Total assets |
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$ |
97,593 |
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$ |
124,712 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
1,437 |
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$ |
1,985 |
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Accrued compensation |
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3,291 |
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4,028 |
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Accrued and other current liabilities |
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4,604 |
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6,370 |
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Deferred revenue |
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— |
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216 |
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Derivative liability related to debt |
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— |
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963 |
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Current portion of long-term debt |
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7,087 |
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3,055 |
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Total current liabilities |
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16,419 |
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16,617 |
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Operating lease liability, net of current portion |
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28,573 |
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30,094 |
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Long-term debt, net |
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12,670 |
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18,409 |
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Other long-term liabilities |
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— |
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23 |
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Total liabilities |
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57,662 |
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65,143 |
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Commitments and contingencies |
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Stockholders’ equity: |
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Common stock |
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7 |
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6 |
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Additional paid-in capital |
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472,187 |
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459,631 |
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Accumulated other comprehensive loss |
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(187 |
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(44 |
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Accumulated deficit |
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(432,076 |
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(400,024 |
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Total stockholders’ equity |
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39,931 |
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59,569 |
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Total liabilities and stockholders’ equity |
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$ |
97,593 |
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$ |
124,712 |
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Media Contact
Evoke Canale Communications
Jason Spark
jason.spark@evokegroup.com
Investor Contact
LifeSci Advisors, LLC
Joyce Allaire
jallaire@lifesciadvisors.com