EX-99.1 2 tm2523281d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

Annovis Provides Corporate Updates and Reports Second Quarter 2025 Financial Results

 

Malvern, Pa., August 12, 2025 – 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 second quarter 2025 financial results.

 

“In the past quarter, our efforts were centered on driving enrollment for the pivotal Phase 3 trial in early AD, which now includes 76 secured clinical sites across the U.S. and over 400 patients screened to date,” said Maria Maccecchini, Ph.D., President and CEO of Annovis. “At the same time, we reached other notable milestones, including presenting our latest scientific findings at AAIC 2025 with the largest attendance ever from Annovis team and strengthening our global intellectual property protection by completing the transfer of all patent families to crystal buntanetap. As we move forward, our focus stays firmly on completing enrollment as planned to produce strong and trustworthy results, while also advancing our Parkinson’s program, with more updates coming as we progress.”

 

Clinical highlights

 

 ·Annovis’ pivotal Phase 3 study in early AD (NCT06709014) is advancing rapidly, with 76 U.S. sites secured and 46 currently enrolling patients. The remaining sites are expected to begin enrollment shortly.
 ·The pivotal Phase 3 trial has attracted strong participation, with 38 patients already receiving buntanetap or placebo and nearly 200 more in screening – a number that continues to grow each day – with screen failure rate being as expected at 50%.

 

Business highlights

 

 ·In April, Annovis welcomed Hui Liu as Director of Biostatistics, who is responsible for maintaining statistical integrity of the data generated by the Company’s clinical trials.
 ·In June, Annovis hosted a webcast to provide updates on its Phase 3 trial, engaging directly with the audience through a live Q&A session. The recording is available in the Video Library on the Company’s website.
 ·In July, senior members of Annovis attended AAIC 2025 in Toronto, presenting four scientific posters highlighting advancements in the Alzheimer’s Phase 3 study and the pharmacokinetic profile of its lead drug candidate, buntanetap. All posters are available in the Media Library on the Company’s website.

 

 

 

 

 ·In August, Annovis announced the successful transfer of all patent families to crystal buntanetap, achieving comprehensive global IP coverage for both the original and new forms of the Company’s drug candidate.

 

Financial results

 

 ·Annovis’ cash and cash equivalents totaled $17.1 million as of June 30, 2025, compared to $10.6 million as of December 31, 2024. The Company had 19.5 million shares of common stock outstanding as of June 30, 2025.
 ·Research and development expenses for the three months ending June 30, 2025, were $5.2 million compared to $5.8 million for the three months ending June 30, 2024.
 ·General and administrative expenses for the three months ending June 30, 2025, were $1.1 million compared to $2.0 million for the three months ending June 30, 2024.
 ·Annovis reported a $0.32 basic and diluted net loss per common share for the three months ending June 30, 2025, compared to a $0.44 basic and diluted net loss per common share for the three months ending June 30, 2024.

 

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)

 

   June 30,   December 31, 
   2025   2024 
Assets          
Current assets:          
Cash and cash equivalents  $17,130,286   $10,551,916 
Prepaid expenses and other current assets   4,324,285    3,373,717 
Total assets  $21,454,571   $13,925,633 
Liabilities and stockholders’ equity          
Current liabilities:          
Accounts payable  $974,311   $2,305,974 
Accrued expenses   1,830,813    1,575,013 
Total current liabilities   2,805,124    3,880,987 
Non-current liabilities:          
Warrant liability   319,000    737,000 
Total liabilities   3,124,124    4,617,987 
Commitments and contingencies          
Stockholders’ equity:          
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, 19,486,231 and 14,141,521 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively   1,948    1,414 
Additional paid-in capital   164,935,088    144,155,694 
Accumulated deficit   (146,606,589)   (134,849,462)
Total stockholders’ equity   18,330,447    9,307,646 
Total liabilities and stockholders’ equity  $21,454,571   $13,925,633 

 

 

 

 

ANNOVIS BIO, INC.

Statements of Operations

(Unaudited)

 

   Three Months Ended   Six Months Ended 
   June 30,   June 30, 
   2025   2024   2025   2024 
Operating expenses:                    
Research and development  $5,161,921   $5,785,217   $10,173,438   $12,307,308 
General and administrative   1,109,532    1,977,421    2,380,696    3,265,137 
Total operating expenses   6,271,453    7,762,638    12,554,134    15,572,445 
Operating loss   (6,271,453)   (7,762,638)   (12,554,134)   (15,572,445)
Other income (expense):                    
Interest income   191,395    25,978    379,007    70,146 
Other financing costs       (1,346,060)       (1,346,060)
Change in fair value of warrants   (140,000)   4,062,308    418,000    10,761,000 
Total other income, net   51,395    2,742,226    797,007    9,485,086 
Net loss  $(6,220,058)  $(5,020,412)  $(11,757,127)  $(6,087,359)
Net loss per share                    
Basic  $(0.32)  $(0.44)  $(0.64)  $(0.56)
Diluted  $(0.32)  $(0.44)  $(0.64)  $(1.52)
Weighted-average number of common shares used in computing net loss per share                    
Basic   19,486,231    11,307,759    18,464,877    10,966,412 
Diluted   19,486,231    11,307,759    18,464,877    11,066,265