Annovis Provides Corporate Updates and Reports Fourth Quarter and Fiscal Year 2024 Financial Results

Rhea-AI Summary

Annovis Bio (NYSE: ANVS) reported its Q4 and FY 2024 financial results, highlighting significant clinical progress in their buntanetap program. The company successfully completed two clinical trials - Phase 2/3 Alzheimer's Disease (AD) and Phase 3 Parkinson's Disease (PD), with promising results in improving cognition and motor function.

Financial highlights include:

• Q4 2024 R&D expenses decreased to $5.0M from $8.9M in Q4 2023
• Q4 2024 net loss per share improved to $0.43 from $2.24 year-over-year
• FY 2024 R&D expenses reduced to $20.0M from $38.8M in 2023
• Cash position of $10.6M as of December 31, 2024
• Completed $21.0M stock offering with ThinkEquity

The FDA cleared Annovis to proceed with a pivotal Phase 3 trial in early AD, launched in early 2025. The study includes a 6-month symptomatic data readout expected in mid-2026 and disease-modifying data in mid-2027, both supporting potential New Drug Applications.

Positive

• Significant reduction in net loss per share from $2.24 to $0.43 in Q4 2024
• FDA clearance received for pivotal Phase 3 AD trial
• Successful completion of Phase 2/3 AD and Phase 3 PD trials with promising results
• Cash position improved to $10.6M from $5.8M year-over-year
• Secured additional $21M through stock offering

Negative

• Increased share count from 14.1M to 19.5M indicates significant dilution
• Continued net losses with -$2.02 per share for FY 2024
• Cash runway only extends into Q4 2025
• G&A expenses increased year-over-year from $6.2M to $6.7M

Insights

Biotechnology Financial Analyst

Annovis' Q4/FY2024 report reveals a substantially improved financial position alongside advancing clinical programs for their lead candidate buntanetap. The completion of two key trials with reported "promising results" in both Alzheimer's and Parkinson's represents significant development progress, culminating in FDA clearance for a pivotal Phase 3 Alzheimer's study that launched in early 2025.

Financially, R&D expenses decreased 43.8% in Q4 and 48.5% for the full year, reflecting the completion of major clinical work. This improved operational efficiency translated to a narrower quarterly loss of $0.43 per share versus $2.24 in Q4 2023. The company's cash position of $10.6 million (up from $5.8 million last year), bolstered by a recent $21 million offering, extends their runway into Q4 2025.

However, investors should note the substantial dilution from this offering, with outstanding shares increasing 38.3% from 14.1 million to 19.5 million. While the current cash position provides runway for approximately 15 months, this timeline may not fully cover the anticipated mid-2026 Phase 3 data readout, potentially necessitating additional financing before reaching this critical milestone.

The company's ability to achieve FDA clearance for their pivotal Phase 3 trial based on Phase 2/3 data suggests regulatory confidence in their approach, though the full validation of buntanetap's effectiveness remains contingent on upcoming trial results in 2026-2027.

Neuroscience Research Analyst

Annovis Bio's development of buntanetap represents an intriguing approach in the challenging neurodegenerative disease space. The company's report of "promising results" from their Phase 2/3 AD and Phase 3 PD trials - specifically citing improvements in both cognition and motor function - suggests potential clinical utility across multiple neurodegenerative conditions.

The FDA's clearance for a pivotal Phase 3 trial in early Alzheimer's is particularly noteworthy, as this indicates the agency found sufficient evidence of efficacy in the subpopulation of early AD patients to justify advancing to a confirmatory study. This strategic focus on early-stage disease aligns with emerging consensus that intervention before extensive neurodegeneration occurs offers the best chance for meaningful clinical benefit.

Buntanetap's mechanism potentially addresses multiple neurotoxic proteins simultaneously, which differentiates it from more targeted approaches like anti-amyloid antibodies. The company's planned two-stage readout strategy - assessing symptomatic benefit at 6 months followed by potential disease-modifying effects at 18 months - reflects a pragmatic approach that could enable sequential approval pathways.

The company's scientific presence at major conferences like CTAD and invitation to present at specialized workshops on Dementia with Lewy Bodies suggests growing recognition within the scientific community. The upcoming Phase 3 readouts in 2026-2027 will be critical in determining whether buntanetap's mechanistic promise translates to clinically meaningful and statistically significant benefits for patients.

MALVERN, Pa., March 21, 2025 (GLOBE NEWSWIRE) -- Annovis Bio Inc. (NYSE: ANVS) ("Annovis" or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today provided corporate updates and fourth quarter/full year 2024 financial results.

In 2024, Annovis made significant progress by advancing the buntanetap program, successfully completing two clinical trials—Phase 2/3 AD and Phase 3 PD. Both studies yielded promising results, reinforcing buntanetap’s ability to improve cognition in AD and PD patients, as well as motor function in PD patients. Building on this success, the FDA cleared Annovis to proceed with a pivotal Phase 3 trial in early AD, which was launched at the start of 2025. The Company also participated in multiple scientific and investor conferences, announced new publications in peer-reviewed journals, expanded its patent portfolio, and added accomplished professionals to its growing team.

“The last year was filled with extraordinary achievements for our company, and we are pleased with our continued momentum into 2025,” said Maria Maccecchini, Ph.D., Founder and CEO of Annovis. “We are deeply grateful to everyone who has supported and believed in our mission. As we move ahead, our focus remains on generating robust data for buntanetap and advancing its path to the patients who need it most.”

Clinical progress

• In October 2024, the FDA granted clearance to proceed with a pivotal Phase 3 study for early AD, based on Phase 2/3 clinical data demonstrating symptomatic improvement in the subgroup of early AD patients.
• In February 2025, Annovis launched the pivotal Phase 3 AD study, which includes a 6-month data readout focused on buntanetap’s symptomatic effects followed by an additional 12-month assessment to evaluate its potential disease-modifying response. The symptomatic data is anticipated in mid-2026, followed by the disease-modifying data in mid-2027, with both expected to support their respective New Drug Applications (NDAs).

Business highlights

• In October 2024, Annovis appointed Matthew Peterson, Ph.D., as Senior Clinical Scientist. In this role, Dr. Peterson ensures the medical, ethical, and scientific integrity of Annovis’ clinical trials, overseeing their initiation, execution, reporting, and successful completion.
• In October and November 2024, Annovis’ leadership participated in key scientific conferences in the neurodegenerative disease space. At the 7th Clinical Trials on Alzheimer’s Disease (CTAD) conference, Annovis presented two posters highlighting findings from its Phase 2/3 AD trial and related biomarker data. Additionally, Annovis was invited to speak at the NIA/NINDS Workshop on Dementia with Lewy Bodies (DLB), where it presented buntanetap’s distinctive mechanism of action and its potential as a treatment for DLB.
• In December 2024, Annovis hosted a year-end webcast, where management addressed key questions from shareholders and provided updates on the Company’s clinical progress and upcoming milestones.
  

Financial results

• Fourth quarter – Research and development expenses for the three months ended December 31, 2024, were $5.0 million compared to $8.9 million for the three months ended December 31, 2023. General and administrative expenses for the three months ended December 31, 2024, were $1.7 million compared to $1.5 million for the three months ended December 31, 2023. Annovis reported a $0.43 basic and diluted net loss per common share for the three months ended December 31, 2024, compared to a $2.24 basic and diluted net loss per common share for the three months ended December 31, 2023.
  
  
• Full year – Research and development expenses for the year ended December 31, 2024, were $20.0 million compared to $38.8 million for the year ended December 31, 2023. General and administrative expenses for the year ended December 31, 2024, were $6.7 million compared to $6.2 million for the year ended December 31, 2023. Annovis reported a $2.02 basic and $2.31 diluted net loss per common share for the year ended December 31, 2024, compared to a $6.23 basic and diluted net loss per common share for the year ended December 31, 2023.
  
  
• Annovis’ cash and cash equivalents totaled $10.6 million as of December 31, 2024, compared to $5.8 million as of December 31, 2023. The Company estimates that its current cash and cash equivalents, which also include proceeds from its recent $21.0 million stock offering with ThinkEquity, will enable it to fund its operations into the fourth quarter of 2025. The Company had 14.1 million shares of common stock outstanding as of December 31, 2024 and 19.5 million shares of common stock outstanding after the offering with ThinkEquity.
  

About Annovis
Headquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as AD and PD. The Company is committed to developing innovative therapies that improve patient outcomes and quality of life. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X.

Investor Alerts
Interested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for email alerts at https://www.annovisbio.com/email-alerts.

Forward-Looking Statements
This press release contains forward-looking statements under the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended. Actual results may differ due to various risks and uncertainties, including those outlined in the Company’s SEC filings under “Risk Factors” in its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update forward-looking statements except as required by law.

Contact Information:
Annovis Bio Inc.
101 Lindenwood Drive
Suite 225
Malvern, PA 19355
www.annovisbio.com

Investor Contact:
Alexander Morin, Ph.D.
Director, Strategic Communications
Annovis Bio
ir@annovisbio.com

(Tables to follow)

ANNOVIS BIO, INC. Balance Sheets (Unaudited)
		As of December 31,
		2024				2023
Assets
Current assets:
Cash and cash equivalents		$	10,551,916			$	5,754,720
Prepaid expenses and other current assets			3,373,717				4,453,544
Total assets		$	13,925,633			$	10,208,264
Liabilities and stockholders’ equity (deficit)
Current liabilities:
Accounts payable		$	2,305,974			$	1,292,837
Accrued expenses			1,575,013				2,986,273
Total current liabilities			3,880,987				4,279,110
Non-current liabilities:
Warrant liability			737,000				13,680,000
Total liabilities			4,617,987				17,959,110
Commitments and contingencies (Note 6)
Stockholders’ equity (deficit) :
Preferred stock - $0.0001 par value, 2,000,000 shares authorized and 0 shares issued and outstanding			—				—
Common stock - $0.0001 par value, 70,000,000 shares authorized and 14,141,521 and 10,519,933 shares issued and outstanding at December 31, 2024 and December 31, 2023, respectively			1,414				1,052
Additional paid-in capital			144,155,694				102,507,189
Accumulated deficit			(134,849,462	)			(110,259,087	)
Total stockholders’ equity (deficit)			9,307,646				(7,750,846	)
Total liabilities and stockholders’ equity (deficit)		$	13,925,633			$	10,208,264

ANNOVIS BIO, INC. Statements of Operations (Unaudited)
		Three Months Ended								Year Ended
		December 31,								December 31,
		2024				2023				2024				2023
Operating expenses:
Research and development		$	4,998,578			$	8,904,730			$	19,995,447			$	38,790,603
General and administrative			1,736,293				1,537,094				6,699,481				6,244,408
Total operating expenses			6,734,871				10,441,824				26,694,928				45,035,011
Operating loss			(6,734,871	)			(10,441,824	)			(26,694,928	)			(45,035,011	)
Other income (expense):
Interest income			126,273				66,130				331,849				667,898
Other financing costs			16,939				—				(1,853,189	)			—
Change in fair value of warrants			727,000				(11,837,200	)			3,625,893				(11,837,200	)
Total other income (expense), net			870,212				(11,771,070	)			2,104,553				(11,169,302	)
Net loss		$	(5,864,659	)		$	(22,212,894	)		$	(24,590,375	)		$	(56,204,313	)
Net loss per share
Basic		$	(0.43	)		$	(2.24	)		$	(2.02	)		$	(6.23	)
Diluted		$	(0.43	)		$	(2.24	)		$	(2.31	)		$	(6.23	)
Weighted-average number of common shares used in computing net loss per share
Basic			13,794,519				9,903,564				12,182,475				9,023,138
Diluted			13,794,519				9,903,564				12,235,444				9,023,138

FAQ

What were Annovis Bio's (ANVS) Q4 2024 financial results?

ANVS reported Q4 2024 R&D expenses of $5.0M, G&A expenses of $1.7M, and a net loss of $0.43 per share, showing improvement from Q4 2023.

When will Annovis Bio (ANVS) report Phase 3 AD trial results?

ANVS expects symptomatic data readout in mid-2026 and disease-modifying data in mid-2027 from the Phase 3 AD trial.

How long can Annovis Bio (ANVS) fund its operations with current cash?

With current cash and proceeds from the $21M ThinkEquity offering, ANVS can fund operations into Q4 2025.

What clinical trials did Annovis Bio (ANVS) complete in 2024?

ANVS completed Phase 2/3 Alzheimer's Disease and Phase 3 Parkinson's Disease trials, both showing promising results.

How many shares of Annovis Bio (ANVS) are outstanding after the ThinkEquity offering?

ANVS has 19.5 million shares outstanding after the ThinkEquity offering, up from 14.1 million as of December 31, 2024.