UNITY Biotechnology, Inc. Reports Second Quarter 2024 Financial Results and Business Updates

Rhea-AI Summary

UNITY Biotechnology (NASDAQ:UBX) reported its Q2 2024 financial results and provided business updates. Key highlights include:

Enrollment Success: The company exceeded its enrollment goal for the ASPIRE study, evaluating UBX1325 against aflibercept in diabetic macular edema (DME).

Financial Position: Cash, cash equivalents, and marketable securities totaled $34.0 million as of June 30, 2024. UNITY believes this is sufficient to fund operations into Q3 2025.

Reduced Net Loss: Q2 2024 net loss was $5.3 million, down from $15.5 million in Q2 2023.

Decreased Expenses: R&D expenses decreased to $3.5 million from $6.4 million, while G&A expenses reduced to $3.5 million from $5.4 million year-over-year.

Study Timeline: Topline 24-week primary endpoint data for the ASPIRE study is expected in Q1 2025, with 36-week data in Q2 2025.

Positive

• Exceeded enrollment goal for ASPIRE study in DME
• Net loss decreased by 65.8% year-over-year to $5.3 million
• R&D expenses reduced by 45.3% to $3.5 million
• G&A expenses decreased by 35.2% to $3.5 million
• Cash used in operations reduced by 56.3% to $9.8 million in H1 2024

Negative

• Cash, cash equivalents and marketable securities decreased by 21.3% to $34.0 million since December 31, 2023

Financial Analyst

UNITY Biotechnology's Q2 2024 results show a significant improvement in financial health. The company's net loss decreased by $10.2 million year-over-year, from $15.5 million to $5.3 million. This 65.8% reduction in net loss is primarily attributed to decreased R&D and G&A expenses.

Cash burn has also improved substantially, with cash used in operations for H1 2024 at $9.8 million, compared to $22.4 million in H1 2023, a 56.3% reduction. This efficiency in cash management is crucial, extending the company's runway into Q3 2025.

However, investors should note the declining cash position, from $43.2 million at the end of 2023 to $34.0 million as of June 30, 2024. While the burn rate has improved, additional financing may be needed before the expected data readouts in 2025.

Medical Research Analyst

UNITY's focus on UBX1325 (foselutoclax) for diabetic macular edema (DME) represents a potentially disruptive approach in ophthalmology. The senolytic mechanism of action, targeting upstream of VEGF inhibitors, could address key limitations of current treatments, particularly the high treatment burden.

The expansion of the ASPIRE study to 50 patients and 36 weeks demonstrates confidence in UBX1325's potential. Exceeding enrollment goals is a positive sign for investor confidence and could accelerate the timeline for data readouts.

However, it's important to note that while promising, the efficacy and durability of UBX1325 compared to aflibercept remain unproven. The upcoming topline 24-week and 36-week data in Q1 and Q2 2025, respectively, will be critical in determining the drug's potential market impact.

SOUTH SAN FRANCISCO, Calif., Aug. 06, 2024 (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, 2024.

“Having expanded and extended our ASPIRE study to 50 patients and 36 weeks, respectively, to better assess the efficacy and durability of UBX1325 compared to aflibercept, we have been laser-focused on enrollment and execution this quarter,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “I’m pleased to report that due to the excellent performance of our clinical operations team and the enthusiasm and engagement of our investigators, we have not just met, but have exceeded our enrollment goal in this study."

UBX1325 (foselutoclax) is designed as a novel and durable therapeutic option in diabetic macular edema (DME) that acts via a senolytic mechanism of action upstream of VEGF inhibitors, with the potential to address shortcomings of the current standard of care, such as high treatment burden and sub-optimal response to treatment.

UNITY expects topline 24-week primary endpoint data in the first quarter of 2025 and 36-week data in the second quarter of 2025. The Phase 2b ASPIRE study in DME is a multi-center, randomized, double-masked, active-controlled study designed to evaluate the safety and efficacy of UBX1325 in a head-to-head comparison to aflibercept. More information about ASPIRE (NCT06011798) can be found here.

Second Quarter Financial Results

Cash, cash equivalents and marketable securities totaled $34.0 million as of June 30, 2024 compared with $43.2 million as of December 31, 2023. UNITY believes that current cash, cash equivalents and marketable securities are sufficient to fund operations into the third quarter of 2025.

Net loss for the three months ended June 30, 2024 was $5.3 million compared to $15.5 million for the three months ended June 30, 2023. Cash used in operations during the first and second quarters of 2024 was $9.8 million compared to $22.4 million during the first and second quarters of 2023.

Research and development expenses decreased by $3.0 million, to $3.5 million for three months ended June 30, 2024 from $6.4 million for the three months ended June 30, 2023. The decrease was primarily due to decreases of $2.0 million in personnel costs due to our reduced headcount related to our reduction in force, $0.7 million in direct research and development expenses mainly due to the completion of the Phase 2 BEHOLD study of UBX1325 in patients with DME and the Phase 2 ENVISION study of UBX1325 in patients with AMD, and $0.3 million in operating costs due to reduced fixed assets depreciation and reduced office space.

General and administrative expenses decreased by $1.9 million, to $3.5 million for the three months ended June 30, 2024 from $5.4 million for the three months ended June 30, 2023. The decrease was primarily due to decreases of $1.2 million in personnel-related expenses due to reduced headcount and the higher bonus and severance amounts paid in 2023, $0.4 million in professional fees and accounting service fees, and $0.3 million in operating costs mainly from the continuation of sublease income generated from the East Grand property.

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 risks related to delay or disruption in 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 the Company in general, see UNITY’s most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the Securities and Exchange Commission on August 6, 2024, 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 (In thousands, except share and per share amounts)
		Three Months Ended								Six Months Ended
		June 30,								June 30,
		2024				2023				2024				2023
		(Unaudited)								(Unaudited)
Operating expenses:
Research and development		$	3,463			$	6,435			$	7,184			$	12,195
General and administrative			3,516				5,413				7,394				10,212
Total operating expenses			6,979				11,848				14,578				22,407
Loss from operations			(6,979	)			(11,848	)			(14,578	)			(22,407	)
Interest income			515				805				1,028				1,660
Interest expense			—				(883	)			—				(1,885	)
Gain (loss) on warrant liability			1,246				(3,461	)			2,622				2,030
Other income (expense), net			(61	)			(69	)			(141	)			(133	)
Net loss			(5,279	)			(15,456	)			(11,069	)			(20,735	)
Other comprehensive gain (loss)
Unrealized gain (loss) on marketable debt securities			3				14				(11	)			115
Comprehensive loss		$	(5,276	)		$	(15,442	)		$	(11,080	)		$	(20,620	)
Net loss per share, basic and diluted		$	(0.31	)		$	(1.07	)		$	(0.66	)		$	(1.44	)
Weighted-average number of shares used in computing net loss per share, basic and diluted			16,815,387				14,425,775				16,800,238				14,369,643

Unity Biotechnology, Inc. Condensed Balance Sheets (In thousands)
		June 30,				December 31,
		2024				2023
		(Unaudited)
Assets
Current Assets:
Cash and cash equivalents		$	7,584			$	19,803
Short-term marketable securities			26,400				23,398
Prepaid expenses and other current assets			1,862				3,404
Total current assets			35,846				46,605
Property and equipment, net			4,630				5,082
Operating lease right-of-use assets			11,900				12,981
Long-term restricted cash			896				896
Other long-term assets			250				126
Total assets		$	53,522			$	65,690
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		$	1,456			$	1,380
Accrued compensation			1,385				1,841
Accrued and other current liabilities			5,977				4,619
Total current liabilities			8,818				7,840
Operating lease liability, net of current portion			21,659				23,539
Warrant liability			3,291				5,913
Total liabilities			33,768				37,292
Commitments and contingencies
Stockholders’ equity:
Common stock			2				2
Additional paid-in capital			515,209				512,773
Accumulated other comprehensive gain			(35	)			(24	)
Accumulated deficit			(495,422	)			(484,353	)
Total stockholders’ equity			19,754				28,398
Total liabilities and stockholders’ equity		$	53,522			$	65,690

Media
Inizio Evoke Comms
Katherine Smith
katherine.smith@inizioevoke.com

Investor Contact
LifeSci Advisors, LLC
Joyce Allaire
jallaire@lifesciadvisors.com

FAQ

What were UNITY Biotechnology's Q2 2024 financial results?

UNITY Biotechnology reported a net loss of $5.3 million for Q2 2024, compared to $15.5 million in Q2 2023. Cash, cash equivalents, and marketable securities totaled $34.0 million as of June 30, 2024.

When does UNITY Biotechnology expect topline data for the ASPIRE study of UBX1325?

UNITY expects topline 24-week primary endpoint data for the ASPIRE study in the first quarter of 2025 and 36-week data in the second quarter of 2025.

How much did UNITY Biotechnology's R&D expenses decrease in Q2 2024?

UNITY Biotechnology's R&D expenses decreased by $3.0 million, from $6.4 million in Q2 2023 to $3.5 million in Q2 2024, primarily due to reduced headcount and completion of previous studies.

What is the cash runway for UNITY Biotechnology (UBX) based on current resources?

UNITY Biotechnology believes that its current cash, cash equivalents, and marketable securities are sufficient to fund operations into the third quarter of 2025.