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

MALVERN, Pa., March 21, 2025 (GLOBE NEWSWIRE) -- Annovis Bio Inc. $(ANVS)$ ("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 
                     ----------    -----------    -----------    ----------- 

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