Aura Biosciences Reports First Quarter 2024 Financial Results and Business Highlights

Rhea-AI Summary

Aura Biosciences, Inc. (NASDAQ: AURA) reported financial results for Q1 2024, highlighting progress in ocular and urologic oncology programs. The company is enrolling in a Phase 3 trial for small choroidal melanoma, with positive pipeline developments in bel-sar treatments for various ocular cancers and bladder cancer. Aura has a strong cash position expected to fund operations until H2 2026.

Positive

• Aura Biosciences is making significant progress in ocular and urologic oncology therapeutic programs.

• Enrollment is ongoing in the global Phase 3 CoMpass trial for small choroidal melanoma, with additional site activations and strong support from the ocular oncology community.

• Bel-sar treatments are being explored for various ocular oncology indications beyond early-stage choroidal melanoma, with a collective incidence of over 60,000 patients annually in the US and Europe.

• The company is initiating clinical development in choroidal metastasis and cancers of the ocular surface, demonstrating positive preclinical data in these areas.

• A Phase 1 trial for bel-sar in bladder cancer is ongoing, with potential to address high unmet needs and provide tissue-specific immune responses.

• Aura Biosciences strengthened its leadership team by appointing Conor Kilroy as General Counsel and Secretary.

• The company reported a strong cash position of $202.9 million, expected to fund operations until the second half of 2026.

Negative

• Research and development expenses increased to $17.1 million for Q1 2024, primarily due to ongoing clinical costs and higher personnel expenses.

• General and administrative expenses also increased to $5.3 million for Q1 2024, driven by personnel expenses and general corporate expenses.

• The net loss for Q1 2024 was $19.7 million, higher than the net loss of $17.5 million for Q1 2023.

Insights

Medical Research Analyst

Aura Biosciences' update on their clinical trials presents a mixed picture for investors. On one hand, the continuation of the Phase 3 CoMpass trial in small choroidal melanoma and the progress in the Phase 1 bladder cancer trial show the company's commitment to advancing its pipeline, which could lead to significant future value if the trials are successful. However, the investment in these trials is reflected in the increased R&D expenses, which have risen from the previous year. While this is expected during intensive trial periods, it's important for investors to monitor the balance between spending and potential returns from these investments. The strong cash position, with over $200 million in reserves, provides a substantial runway into 2026, which suggests the company is financed sufficiently to see through its current trials without the immediate need for additional capital raising. This is a positive signal, as it may reduce dilution risk for current shareholders in the short-term. However, if clinical data fail to meet expectations or if there are delays in the trial progress, the stock could face downward pressure. In terms of the Pipeline Developments, Aura's expansion into multiple ocular oncology indications increases the potential market for their drug bel-sar. But, these are early days and the preclinical and early clinical trial data should be interpreted with caution as many compounds fail to transition from early success to market approval. The Fast Track designation for NMIBC is a positive, as it may expedite the review process and potentially bring the treatment to market more quickly if positive data emerge.

Financial Analyst

From a financial perspective, Aura Biosciences' first quarter report for 2024 shows a strategic focus on research and development, with a notable increase in related expenses. This increase is a reflection of the company's investment in advancing its clinical programs. Investors should interpret these financials with an understanding that biotech firms often operate at a loss while developing their products. The critical factor for Aura's financial health will be its ability to manage these expenses while moving its drug candidates towards commercialization. An important aspect to consider is the cash burn rate, with the company stating it has enough cash to fund operations into the second half of 2026. This provides a cushion for the company to execute its clinical development plans without the immediate need for further fundraising, which could be dilutive to shareholders. However, the net loss has widened compared to the previous year, something not uncommon in biotech but still a point of attention. Investors should also watch for milestones such as the expected mid-2024 data from the bladder cancer trial which, if positive, might offer share price catalysts or, conversely, could trigger volatility if results are underwhelming.

Oncology Doctor

As an oncology specialist, the clinical advancement of Aura's product bel-sar holds promise for addressing significant unmet needs in ocular and urologic oncology. The global Phase 3 CoMpass trial, if successful, could introduce a new standard of care for choroidal melanoma, an ocular malignancy with limited treatment options that preserve vision. The trial's primary endpoint of time to tumor progression will be pivotal in determining the drug's efficacy. Meanwhile, the exploration of bel-sar in bladder cancer, with early Phase 1 data expected soon, could potentially reshape the treatment landscape for a disease that sees a high number of cases each year. The approach of inducing an immunogenic cell death is particularly intriguing as it might offer a way to activate the body's immune system to fight the cancer, which is an area of significant interest and research in oncology. However, the long road from clinical trials to clinical practice is fraught with challenges and therapeutic candidates that show promise in early trials may not always translate into viable treatments. Thus, while the scientific rationale behind bel-sar is compelling, the outcomes of these trials will be important in assessing the drug's real-world applicability and potential impact on patient care.

Continued Enrollment in Global Phase 3 CoMpass Trial in Small Choroidal Melanoma and Indeterminate Lesions

Ongoing Phase 1 Trial in Bladder Cancer Enrolling; Early Data Expected Mid-2024

Strong Cash Position Expected to Fund Operations into Second Half of 2026

BOSTON, May 09, 2024 (GLOBE NEWSWIRE) -- Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision immunotherapies to treat solid tumors designed to preserve the function of the organ with cancer, today reported financial results for the first quarter ended March 31, 2024, and provided recent business highlights.

“Throughout the first quarter of 2024, the Company made significant progress across our ocular and urologic oncology therapeutic area programs,” said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. “Enrollment continues in our global Phase 3 CoMpass trial in early-stage choroidal melanoma, and we expect early Phase 1 data from our bladder cancer trial mid-2024. Aura is committed to changing the treatment paradigms in ocular and urologic oncology, both areas where patients desperately need novel therapies that can effectively treat the tumor and also preserve the function of the organ with cancer.”

Recent Pipeline Developments

Enrollment continues in global Phase 3 CoMpass trial for the treatment of small choroidal melanoma and indeterminate lesions.

• The CoMpass trial continues to progress in the United States with additional site activations and a strong endorsement from the ocular oncology community. This trial has a global enrollment target of approximately 100 patients.
  
  
• CoMpass is a global, Phase 3, randomized, superiority trial evaluating bel-sar treatment against a sham control arm. Adult participants will be randomized 2:1:2 to undergo three cycles of treatment with either a high or low dose of bel-sar or to receive a sham control. The primary endpoint is time to tumor progression at 15 months of follow-up, as agreed upon with the United States Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA).
  

Bel-sar is being explored for additional ocular oncology indications.

In addition to early-stage choroidal melanoma, bel-sar is also being explored for choroidal metastasis and cancers of the ocular surface. These three ocular oncology indications have a collective incidence greater than 60,000 patients annually in the United States and Europe.

Choroidal Metastasis
The Company’s plan is to initiate clinical development in choroidal metastasis, an indication with a high unmet medical need and no drugs approved. Choroidal metastasis is the second potential ocular oncology indication for bel-sar, affecting approximately 20,000 patients in the United States and Europe annually. The Company is on track to initiate a Phase 2 trial in 2024.

Cancers of the Ocular Surface
Cancers of the ocular surface is the Company’s third potential ocular oncology indication affecting approximately 35,000 patients in the United States and Europe annually. Positive preclinical data evaluating bel-sar in this indication were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting.

These preclinical data demonstrate that binding of bel-sar was consistent across all conjunctival melanoma cell lines tested which included both primary and recurrent cell lines. The mechanism of action was also consistent with prior preclinical data presented by the Company demonstrating that bel-sar induced immunogenic cell death, which was characterized by enhanced exposure of damaged associated molecular patterns (DAMPs) and engulfment by THP1-derived macrophages. We believe these recent preclinical data further support clinical development of bel-sar in cancers of the ocular surface.

A Phase 1 trial of bel-sar for the treatment of non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC) is currently ongoing, with early data expected in mid-2024.

NMIBC and MIBC represent an area of high unmet need with approximately 80,000 patients diagnosed in the United States annually. We believe bel-sar has the potential to selectively treat and induce a tissue and tumor specific immune response to prevent disease progression and recurrence while allowing the patients to be treated in the office by urologists and potentially avoiding the need for surgery. The Company received Fast Track designation from the Oncology Division of the FDA for NMIBC in June 2022.

• The ongoing Phase 1 multi-center, open-label clinical trial is expected to enroll approximately 21 adult patients. The trial is designed to assess the safety and feasibility of bel-sar as a monotherapy. The trial includes histopathological evaluation after local treatment to assess bel-sar’s biological activity, including the evaluation of focal necrosis and immune activation.
  
  
• Preliminary data from the first patient in the light activated cohort of the trial demonstrated a clinical complete response demonstrated by absence of cancer cells on histopathology with evidence of extensive necrosis and immune activation after a single administration of bel-sar followed by light activation.
  
  
• Phase 1 trial continues to enroll, with early data expected mid-2024.
  

Recent Corporate Events

Strengthened leadership team with appointment of Conor Kilroy as General Counsel and Secretary.

• Mr. Kilroy previously served as general counsel and secretary at Neurogastrx, Inc. and Ironwood Pharmaceuticals, Inc., among other roles. He brings years of legal experience in the biopharmaceutical industry across clinical and commercial stage organizations.
  

First Quarter 2024 Financial Results

• As of March 31, 2024, Aura had cash and cash equivalents and marketable securities totaling $202.9 million. The Company believes its current cash and cash equivalents and marketable securities are sufficient to fund its operations into the second half of 2026.
  
  
• Research and development expenses increased to $17.1 million for the three months ended March 31, 2024 from $14.4 million for the three months ended March 31, 2023, primarily due to ongoing clinical costs related to the progression of our Phase 2 study of bel-sar in early-stage choroidal melanoma and contract research organization costs associated with the advancement of our Phase 3 trial of bel-sar in early-stage choroidal melanoma and higher personnel expenses related to growth of our Company.
  
  
• General and administrative expenses increased to $5.3 million for the three months ended March 31, 2024 from $5.0 million for the three months ended March 31, 2023. General and administrative expenses include $1.4 million and $1.1 million of stock-based compensation for the three months ended March 31, 2024 and 2023, respectively. The increase was primarily driven by personnel expenses, as well as increases in general corporate expenses related to the growth of our Company.
  
  
• Net loss for the three months ended March 31, 2024 was $19.7 million compared to $17.5 million for the three months ended March 31, 2023.
  

About Aura Biosciences

Aura Biosciences is a clinical-stage biotechnology company developing precision immunotherapies to treat solid tumors designed to preserve the function of the organ with cancer. Our lead candidate bel-sar is in late-stage clinical development for the treatment of patients with primary choroidal melanoma, and other ocular oncology indications as well as in early-stage clinical development in bladder cancer. We are evaluating the safety and efficacy of bel-sar as a potential vision-sparing therapy in an ongoing global Phase 3 CoMpass trial for the first-line treatment of adult patients with early-stage choroidal melanoma. Bel-sar is also being evaluated in additional solid cancers, including bladder cancer. Our mission is to develop vision and organ-sparing therapies to improve patient outcomes in cancer. Aura is headquartered in Boston, MA. For more information, visit aurabiosciences.com. Visit us @AuraBiosciences and on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. Any statements that are not statements of historical fact may be deemed to be forward looking statements. Words such as “may,” “will,” “could,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “seeks,” “endeavor,” “potential,” “continue” or the negative of such words or other similar expressions that can be used to identify forward-looking statements. These forward looking statements include express or implied statements regarding Aura’s future expectations, plans and prospects, including, without limitation, statements regarding the therapeutic potential of bel-sar for the treatment of cancers including choroidal melanoma, bladder cancer, choroidal metastasis and cancers of the ocular surface; statements regarding the Company’s expectations for the Phase 2 and Phase 3 clinical trials of bel-sar for small choroidal melanoma and indeterminate lesions, the Phase 1 trial of bel-sar for NMIBC and MIBC and the clinical development of bel-sar in choroidal metastasis and cancers of the ocular surface; statements regarding the Company’s expectations for an improved quality of life of patients after treatment with bel-sar; statements regarding the Company’s expectations for a potential paradigm shift in the approach to the treatment of choroidal melanoma; statements regarding the Company’s beliefs and expectations for the urgent need for a targeted therapy in ocular and urologic oncology to preserve the function of the organ with cancer; and statements regarding the Company’s expectations for the estimated patient populations and related market opportunities for bel-sar.

The forward-looking statements in this press release are neither promises nor guarantees, and investors should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors, many of which are beyond Aura’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements, including, without limitation, uncertainties inherent in clinical trials and in the availability and timing of data from ongoing clinical trials; the expected timing for submissions for regulatory approval or review by governmental authorities; the risk that the results of Aura’s preclinical and clinical trials may not be predictive of future results in connection with future clinical trials; the risk that interim data from ongoing clinical trials may not be predictive of final data from completed clinical trials; the risk that governmental authorities may disagree with Aura’s clinical trial designs, even where Aura has obtained agreement with governmental authorities on the design of such trials, such as the Phase 3 SPA agreement with the FDA; whether Aura will receive regulatory approvals to conduct trials or to market products; whether Aura’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; Aura’s ongoing and planned preclinical activities; and Aura’s ability to initiate, enroll, conduct or complete ongoing and planned clinical trials. These risks, uncertainties and other factors include those risks and uncertainties described under the heading “Risk Factors” in Aura’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the United States Securities and Exchange Commission (SEC) and in subsequent filings made by Aura with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Aura disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Aura’s current expectations and speak only as of the date hereof and no representations or warranties (express or implied) are made about the accuracy of any such forward-looking statements.

Investor and Media Contact:

Alex Dasalla
Head of Investor Relations and Corporate Communications
IR@aurabiosciences.com

Aura Biosciences, Inc. Condensed Consolidated Statement of Operations and Comprehensive Loss (Unaudited) (in thousands, except share and per share amounts)
		Three Months Ended March 31,
		2024				2023
Operating Expenses:
Research and development		$	17,052			$	14,405
General and administrative			5,261			$	5,039
Total operating expenses			22,313				19,444
Total operating loss			(22,313	)			(19,444	)
Other income (expense):
Interest income, including amortization and accretion income			2,685				1,991
Other income (expense)			(32	)			(13	)
Total other income			2,653				1,978
Loss before income taxes			(19,660	)			(17,466	)
Income tax benefit (provision), net			(46	)			—
Net loss			(19,706	)			(17,466	)
Net loss per common share—basic and diluted			(0.40	)			(0.46	)
Weighted average common stock outstanding—basic and diluted			49,451,943				37,784,282
Comprehensive loss:
Net loss		$	(19,706	)		$	(17,466	)
Other comprehensive items:
Unrealized gain (loss) on marketable securities		$	(521	)			27
Total other comprehensive income (loss)			(521	)			27
Total comprehensive loss		$	(20,227	)		$	(17,439	)

Aura Biosciences, Inc. Condensed Consolidated Balance Sheets (Unaudited) (in thousands, except share and per share amounts)
		March 31, 2024				December 31, 2023
Assets
Current assets:
Cash and cash equivalents		$	26,279			$	41,063
Marketable securities			176,595				185,087
Restricted cash and deposits			—				19
Prepaid expenses and other current assets			9,375				5,625
Total current assets			212,249				231,794
Restricted cash and deposits, net of current portion			768				768
Right of use assets - operating lease			18,501				18,854
Other long-term assets			453				509
Property and equipment, net			3,054				3,150
Total Assets		$	235,025			$	255,075
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable			1,933				1,787
Short-term operating lease liability			2,741				2,687
Accrued expenses and other current liabilities			4,989				7,883
Total current liabilities			9,663				12,357
Long-term operating lease liability			16,579				16,870
Total Liabilities			26,242				29,227
Commitments and Contingencies
Stockholders’ Equity:
Common stock, $0.00001 par value, 150,000,000 authorized at March 31, 2024 and December 31, 2023, and 49,504,405 and 49,350,788 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively			—				—
Additional paid-in capital			515,779				512,617
Accumulated deficit			(307,014	)			(287,308	)
Accumulated other comprehensive loss			18				539
Total Stockholders’ Equity			208,783				225,848
Total Liabilities and Stockholders’ Equity		$	235,025			$	255,075

 

FAQ

What is Aura Biosciences currently enrolling in?

Aura Biosciences is currently enrolling in the global Phase 3 CoMpass trial for small choroidal melanoma.

What are the potential ocular oncology indications for bel-sar?

Bel-sar is being explored for choroidal metastasis and cancers of the ocular surface, besides early-stage choroidal melanoma.

What is the expected timeline for the Phase 1 trial of bel-sar in bladder cancer?

Early data for the Phase 1 trial of bel-sar in bladder cancer is expected in mid-2024.

What was Aura Biosciences' net loss for the first quarter of 2024?

Aura Biosciences reported a net loss of $19.7 million for the first quarter of 2024.

What is the company's cash position as of March 31, 2024?

Aura Biosciences had cash and cash equivalents totaling $202.9 million as of March 31, 2024.