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BioAge Labs Reports Third Quarter 2024 Financial Results and Provides Business Updates

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BioAge Labs reported Q3 2024 financial results and business updates. Key highlights include the initiation of Phase 2 STRIDES trial testing azelaprag with tirzepatide for obesity, and completion of a $238.3M IPO. The company reported R&D expenses of $20.0M (up from $6.5M in Q3 2023), G&A expenses of $4.7M, and a net loss of $23.4M. With approximately $334.5M in cash and cash equivalents, BioAge expects to fund operations into 2029. The company also appointed former GSK CEO Jean-Pierre Garnier as Board Chair.

BioAge Labs ha riportato i risultati finanziari del terzo trimestre 2024 e aggiornamenti aziendali. I punti salienti includono l'inizio della fase 2 della sperimentazione STRIDES che testa l'azelaprag con il tirzepatide per l'obesità e il completamento di un'IPO da 238,3 milioni di dollari. L'azienda ha registrato spese per R&S di 20,0 milioni di dollari (in aumento rispetto ai 6,5 milioni di dollari del terzo trimestre 2023), spese generali e amministrative di 4,7 milioni di dollari e una perdita netta di 23,4 milioni di dollari. Con circa 334,5 milioni di dollari in contanti e equivalenti, BioAge prevede di finanziare le operazioni fino al 2029. L'azienda ha anche nominato l'ex CEO di GSK, Jean-Pierre Garnier, come presidente del consiglio.

BioAge Labs informó los resultados financieros del tercer trimestre de 2024 y actualizaciones de la empresa. Los puntos clave incluyen el inicio del ensayo STRIDES de fase 2, que prueba el azelaprag con tirzepatide para la obesidad, y la finalización de una OPI de 238,3 millones de dólares. La empresa reportó gastos en I+D de 20,0 millones de dólares (un aumento desde los 6,5 millones de dólares en el tercer trimestre de 2023), gastos generales y administrativos de 4,7 millones de dólares, y una pérdida neta de 23,4 millones de dólares. Con aproximadamente 334,5 millones de dólares en efectivo y equivalentes, BioAge espera financiar sus operaciones hasta 2029. La compañía también nombró al ex-CEO de GSK, Jean-Pierre Garnier, como presidente de la junta.

BioAge Labs는 2024년 3분기 재무 결과 및 사업 업데이트를 발표했습니다. 주요 내용으로는 비만 치료를 위해 azelaprag와 tirzepatide를 시험하는 2상 STRIDES 임상 시험의 시작과 2억 3,830만 달러 규모의 IPO 완료가 포함됩니다. 회사는 2023년 3분기의 650만 달러에서 증가한 2천만 달러의 연구 개발비, 470만 달러의 일반 관리비, 2천3백40만 달러의 순손실을 기록했습니다. BioAge는 약 3억 3천4백50만 달러의 현금 및 현금성 자산을 보유하고 있으며 2029년까지 운영 자금을 지원할 것으로 예상하고 있습니다. 또한 회사는 전 GSK CEO인 장-피에르 가르니에를 이사회 의장으로 임명했습니다.

BioAge Labs a publié les résultats financiers du troisième trimestre 2024 ainsi que des mises à jour sur son activité. Les points clés incluent le lancement de l'essai STRIDES de phase 2 testant l'azelaprag avec tirzepatide pour l'obésité et l'achèvement d'une introduction en bourse de 238,3 millions de dollars. L'entreprise a déclaré des dépenses de R&D de 20,0 millions de dollars (en hausse par rapport à 6,5 millions de dollars au troisième trimestre 2023), des dépenses générales et administratives de 4,7 millions de dollars, et une perte nette de 23,4 millions de dollars. Avec environ 334,5 millions de dollars en liquidités et équivalents, BioAge prévoit de financer ses opérations jusqu'en 2029. La société a également nommé l'ancien PDG de GSK, Jean-Pierre Garnier, président du conseil d'administration.

BioAge Labs hat die Finanzzahlen des dritten Quartals 2024 und Unternehmensupdates berichtet. Zu den wichtigsten Punkten gehört der Beginn der Phase-2-STRIDES-Studie zur Erprobung von Azelaprag mit Tirzepatid zur Behandlung von Fettleibigkeit sowie der Abschluss eines Börsengangs (IPO) über 238,3 Millionen Dollar. Das Unternehmen meldete F & E-Ausgaben von 20,0 Millionen Dollar (ein Anstieg von 6,5 Millionen Dollar im dritten Quartal 2023), allgemeine und administrative Ausgaben von 4,7 Millionen Dollar und einen Nettoverlust von 23,4 Millionen Dollar. Mit etwa 334,5 Millionen Dollar an Bargeld und liquiden Mitteln erwartet BioAge, die Betriebskosten bis 2029 zu decken. Das Unternehmen ernannte außerdem den ehemaligen GSK-CEO Jean-Pierre Garnier zum Vorstandsvorsitzenden.

Positive
  • Successful completion of $238.3M IPO and private placement
  • Strong cash position of $334.5M sufficient to fund operations into 2029
  • Initiated Phase 2 STRIDES trial for obesity treatment
  • Strategic collaboration with Eli Lilly's Chorus clinical development organization
Negative
  • Net loss increased to $23.4M from $14.6M in Q3 2023
  • R&D expenses tripled to $20.0M from $6.5M YoY
  • G&A expenses increased by $1.3M to $4.7M YoY

Insights

BioAge's Q3 results showcase a strong financial position following their successful IPO and private placement, raising total net proceeds of $217.1 million. With $334.5 million in cash reserves, their runway extends into 2029, providing exceptional operational flexibility. However, the increased R&D expenses of $20.0 million (up 207% YoY) and widening net loss of $23.4 million reflect aggressive investment in clinical development, particularly the STRIDES trial.

The collaboration with Eli Lilly's Chorus organization for the Phase 2 STRIDES trial adds credibility to their obesity treatment program. The appointment of former GSK CEO as Board Chair brings valuable big pharma expertise and could enhance future partnership opportunities. The stock appears well-positioned for long-term growth, backed by strong cash reserves and strategic developments in the lucrative obesity market.

The STRIDES trial represents a significant strategic approach in the obesity treatment landscape, combining azelaprag with tirzepatide. This dual-mechanism strategy targeting both apelin receptor activation and GLP-1/GIP pathways could potentially enhance weight loss outcomes while promoting healthier body composition. The anticipated timeline for top-line results in Q3 2025 provides a clear catalyst for clinical validation.

The collaboration with Eli Lilly is particularly noteworthy, as tirzepatide (Zepbound/Mounjaro) is currently leading the obesity treatment market. If successful, this combination therapy could address limitations of current incretin-based treatments, potentially offering improved efficacy through an oral add-on therapy. The focus on metabolic aging biology also differentiates their approach in the competitive obesity therapeutics space.

Initiated Phase 2 STRIDES trial of azelaprag in combination with tirzepatide for obesity

Completed $238.3 million initial public offering and concurrent private placement, cash and cash equivalents sufficient to fund operations and capital expenditures into 2029

Appointed former GSK CEO Jean-Pierre Garnier as Board Chair

RICHMOND, Calif., Nov. 07, 2024 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. ("BioAge", “the Company”), a clinical-stage biotechnology company developing therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of human aging, today provided business updates and reported its third quarter 2024 financial results.

"The third quarter of 2024 was transformative for BioAge as we achieved two major milestones: initiating our Phase 2 STRIDES trial evaluating azelaprag in combination with tirzepatide, and completing our IPO,” said Kristen Fortney, Ph.D., CEO and co-founder of BioAge. "The STRIDES trial is a critical step in our mission to improve outcomes for patients with obesity. We're developing an oral therapy that has the potential to enhance the weight loss benefits of incretin drugs while promoting healthy body composition. With our strong cash position following our IPO, we are well-equipped to advance our clinical programs and continue developing innovative therapies that target the biology of metabolic aging."

Third Quarter 2024 Business Highlights

Clinical trials

  • In July 2024, BioAge dosed the first patient in the STRIDES Phase 2 clinical trial evaluating BioAge’s lead compound azelaprag, an oral small-molecule apelin receptor agonist, as a novel treatment for obesity in combination with tirzepatide. STRIDES is being conducted in collaboration with Eli Lilly & Company’s Chorus clinical development organization. Top-line results are anticipated in the third quarter of 2025.

Corporate Updates

  • In August 2024, BioAge appointed Jean-Pierre Garnier, PhD, former CEO of GlaxoSmithKline, as Chair of the Board of Directors, succeeding James Healy, MD, PhD, who remains on the Board as a Director.
  • In September 2024, BioAge received approximately $189.5 million in net proceeds from its initial public offering and concurrent private placement.
  • In October 2024, the underwriters of BioAge’s IPO exercised in full their option to purchase additional shares of the Company’s common stock, yielding approximately $27.6 million in net proceeds.
  • Total IPO proceeds and existing cash and cash equivalents extend cash runway into 2029.

Third Quarter 2024 Financial Results

Research and development expenses were $20.0 million for the quarter ended September 30, 2024, compared to $6.5 million for the same period in 2023. The $13.5 million increase in research and development expenses was primarily attributable to a $12.0 million increase in costs related to the development of azelaprag driven by the ongoing Phase 2 STRIDES trial and costs related to the manufacture of azelaprag.

General and administrative expenses were $4.7 million for the quarter ended September 30, 2024, compared to $3.4 million for the same period in 2023. The $1.3 million increase was primarily attributable to an increase in stock-based compensation expense associated with option grants issued in 2024 to employees, executives, board members and advisors.

Net loss was $23.4 million for the quarter ended September 30, 2024, or $6.70 per weighted-average common share outstanding, basic and diluted, compared to a net loss of $14.6 million, or $8.74 per weighted-average common share outstanding, basic and diluted, for the same period in 2023.

As of September 30, 2024, BioAge had approximately $334.5 million in cash and cash equivalents. Based on our current operating plan, BioAge estimates that existing cash and cash equivalents, together with the net proceeds received in October 2024 from the purchase of additional shares of common stock by the underwriters of BioAge’s IPO, will be sufficient to fund operations and capital expenses into 2029.

About BioAge Labs, Inc.

BioAge is a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of human aging. BioAge’s lead product candidate, azelaprag, is an orally available small molecule agonist of APJ that was observed to promote metabolism and prevent muscle atrophy on bed rest in a Phase 1b clinical trial. In mid-2024, BioAge initiated a Phase 2 trial of azelaprag in combination with tirzepatide for the treatment of obesity in older adults. Azelaprag has potential as an oral regimen to amplify weight loss and improve body composition in patients on obesity therapy with incretin drugs. BioAge is also developing orally available small molecule brain penetrant NLRP3 inhibitors for the treatment of diseases driven by neuroinflammation.  BioAge’s preclinical programs, based on novel insights from the company’s discovery platform built on human longevity data, address key pathways in metabolic aging.

Forward-looking statements

This press release contains “forward-looking statements” within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our plans to develop and commercialize our product candidates, the timing and results of our ongoing or planned clinical trials, risks associated with clinical trials, including our ability to adequately manage clinical activities, the timing of and our ability to obtain and maintain regulatory approvals, the clinical utility of our product candidates, the sufficiency of our cash and cash equivalents, general economic, industry and market conditions. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “potential,” “possible,” “will,” “would,” and other words and terms of similar meaning. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our ability to develop, obtain regulatory approval for and commercialize our product candidates; the timing and results of preclinical studies and clinical trials; the risk that positive results in a preclinical study or clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive of results in later stage clinical trials; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events; failure to protect and enforce our intellectual property, and other proprietary rights; failure to successfully execute or realize the anticipated benefits of our strategic and growth initiatives; risks relating to technology failures or breaches; our dependence on collaborators and other third parties for the development of product candidates and other aspects of our business, which are outside of our full control; risks associated with current and potential delays, work stoppages, or supply chain disruptions; risks associated with current and potential future healthcare reforms; risks relating to attracting and retaining key personnel; failure to comply with legal and regulatory requirements; risks relating to access to capital and credit markets; and the other risks and uncertainties that are detailed under the heading “Risk Factors” included in BioAge’s prospectus dated September 25, 2024 filed with the U.S. Securities and Exchange Commission (SEC) on September 26, 2024, and BioAge’s annual and quarterly reports and other filings with the SEC filed from time to time. BioAge undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.


Contacts
PR: Chris Patil, media@bioagelabs.com
IR: Elena Liapounova, ir@bioagelabs.com
Partnering: partnering@bioagelabs.com
Web: https://bioagelabs.com

BioAge Labs, Inc.
Unaudited Condensed Consolidated Statement of Operations and Comprehensive Loss
(In thousands, except share and per share data)
 
 Three Months Ended  Nine Months Ended 
 September 30,  September 30, 
 2024  2023  2024  2023 
Operating expenses:           
Research and development$20,019  $6,532  $39,811  $23,804 
General and administrative 4,731   3,355   13,021   11,000 
Total operating expenses 24,750   9,887   52,832   34,804 
Loss from operations (24,750)  (9,887)  (52,832)  (34,804)
Other income (expense), net:           
Interest expense (388)  (2,403)  (2,048)  (5,235)
Interest and other income 2,037   499   5,534   2,052 
Loss from changes in fair value of warrants and derivative liabilities (306)  (2,834)  (384)  (4,909)
Loss on extinguishment of debt       (250)   
Total other income (expense), net 1,343   (4,738)  2,852   (8,092)
Net loss$(23,407) $(14,625) $(49,980) $(42,896)
Net loss per share attributable to common stockholders, basic and diluted$(6.70) $(8.74) $(21.76) $(25.64)
Weighted-average common shares outstanding, basic and dilutive 3,494,580   1,672,726   2,297,397   1,672,701 
Comprehensive loss:           
Net loss (23,407)  (14,625)  (49,980)  (42,896)
Foreign currency translation adjustment 58   35   55   67 
Total comprehensive loss$(23,349) $(14,590) $(49,925) $(42,829)
                


BioAge Labs, Inc.
Unaudited Condensed Consolidated Balance Sheets
(In thousands)
 
 September 30,  December 31, 
 2024  2023 
Assets     
Current Assets:     
Cash and cash equivalents$334,474  $21,644 
Restricted cash    3,313 
Prepaid expenses and other current assets 1,993   349 
Total current assets 336,467   25,306 
Investments 100   100 
Property and equipment, net 543   323 
Operating right-of-use assets, net 271   195 
Total assets$337,381  $25,924 
Liabilities     
Current Liabilities:     
Accounts payable$2,098  $1,866 
Accrued expenses and other current liabilities 10,709   7,938 
Current portion of term loan 6,000   6,000 
Operating lease liabilities, current 273   194 
Convertible promissory notes    20,674 
Convertible promissory notes embedded derivative liability    18,183 
Deferred grant income    3,313 
Total current liabilities 19,080   58,168 
Term loan 3,940   8,201 
Warrant liability 613   229 
Total liabilities 23,633   66,598 
Redeemable convertible preferred stock, par value of $0.00001, 31,634,362 shares authorized as of December 31, 2023, and 31,465,128 shares issued and outstanding as of December 31, 2023; aggregate liquidation preference of $131,864 as of December 31, 2023; no shares issued and outstanding as of September 30, 2024    132,722 
Commitments and Contingencies (Note 8)     
Stockholders’ Equity (Deficit)     
Common stock, $0.00001 par value; 500,000,000 and 52,400,000 shares authorized as of September 30, 2024 and December 31, 2023, respectively; 34,196,821 and 1,673,314 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively     
Preferred stock, $0.00001 par value; 10,000,000 shares authorized as of September 30, 2024; no shares issued and outstanding as of September 30, 2024; no shares authorized, issued, or outstanding as of December 31, 2023     
Additional paid-in-capital 545,321   8,142 
Accumulated other comprehensive income 109   164 
Accumulated deficit (231,682)  (181,702)
Total stockholders’ equity (deficit) 313,748   (173,396)
Total liabilities and stockholders’ equity (deficit)$337,381  $25,924 

FAQ

What were BioAge Labs (BIOA) Q3 2024 financial results?

BioAge reported a net loss of $23.4M, R&D expenses of $20.0M, and G&A expenses of $4.7M for Q3 2024. The company had $334.5M in cash and cash equivalents.

How much did BioAge Labs (BIOA) raise in its IPO in 2024?

BioAge raised approximately $238.3M through its initial public offering and concurrent private placement, including $27.6M from the full exercise of underwriters' option.

When will BioAge Labs (BIOA) STRIDES trial results be available?

Top-line results from the Phase 2 STRIDES trial evaluating azelaprag with tirzepatide are anticipated in the third quarter of 2025.

How long will BioAge Labs (BIOA) current cash reserves last?

Based on current operating plans, BioAge's cash reserves of $334.5M are expected to fund operations and capital expenses into 2029.

BioAge Labs, Inc.

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