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Ainos Reports Third Quarter 2024 Financial Results

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Ainos (NASDAQ:AIMD) reported Q3 2024 financial results with zero revenue compared to $24,489 in Q3 2023. The company reported a net loss of $3.7M, up from $3.0M in Q3 2023. Operating expenses increased to $3.0M from $2.6M, primarily due to higher R&D investments. Cash position strengthened to $5.2M as of September 30, 2024.

Key developments include securing multi-regional patent assets for AI Nose technology, expanding VELDONA® patent portfolio for coronavirus treatments, and progressing clinical trials for Sjögren's syndrome and HIV-related oral warts. The AI Nose platform achieved 79% accuracy in detecting VOCs in semiconductor factories.

Ainos (NASDAQ:AIMD) ha riportato i risultati finanziari del Q3 2024 con un fatturato pari a zero, rispetto ai $24,489 del Q3 2023. L'azienda ha registrato una perdita netta di $3.7 milioni, in aumento dai $3.0 milioni del Q3 2023. Le spese operative sono aumentate a $3.0 milioni rispetto ai $2.6 milioni, principalmente a causa di maggiori investimenti in R&S. La posizione di cassa è migliorata a $5.2 milioni al 30 settembre 2024.

Sviluppi chiave includono l'acquisizione di beni brevettuali multi-regionali per la tecnologia AI Nose, l'espansione del portafoglio brevettuale VELDONA® per i trattamenti contro il coronavirus e il progresso degli studi clinici per la sindrome di Sjögren e le verruche orali correlate all'HIV. La piattaforma AI Nose ha raggiunto il 79% di accuratezza nel rilevamento dei VOC nelle fabbriche di semiconduttori.

Ainos (NASDAQ:AIMD) reportó resultados financieros del Q3 2024 con ingresos de cero en comparación con $24,489 en el Q3 2023. La compañía reportó una pérdida neta de $3.7 millones, en comparación con los $3.0 millones del Q3 2023. Los gastos operativos aumentaron a $3.0 millones desde $2.6 millones, principalmente debido a mayores inversiones en I+D. La posición de efectivo se fortaleció a $5.2 millones al 30 de septiembre de 2024.

Los desarrollos clave incluyen la obtención de activos de patentes multi-regionales para la tecnología AI Nose, la expansión del portafolio de patentes de VELDONA® para tratamientos de coronavirus y el avance en ensayos clínicos para el síndrome de Sjögren y las verrugas orales relacionadas con el VIH. La plataforma AI Nose logró un 79% de precisión en la detección de VOC en fábricas de semiconductores.

Ainos (NASDAQ:AIMD)는 2024년 3분기 재무 결과를 보고하며, 2023년 3분기의 $24,489와 비교해 수익이 0임을 알렸습니다. 회사는 2023년 3분기의 $3.0백만에서 증가한 $3.7백만의 순손실을 기록했습니다. 운영비용은 $2.6백만에서 $3.0백만으로 증가했으며, 주로 R&D 투자 증가 때문입니다. 2024년 9월 30일 기준 현금 보유액은 $5.2백만으로 강화되었습니다.

주요 개발 사항으로는 AI Nose 기술을 위한 다지역 특허 자산 확보, coronavirus 치료를 위한 VELDONA® 특허 포트폴리오 확장, 그리고 쇼그렌 증후군 및 HIV 관련 구강 사마귀에 대한 임상 시험 진행이 포함됩니다. AI Nose 플랫폼은 반도체 공장에서 VOC를 탐지하는 데 79%의 정확도를 달성했습니다.

Ainos (NASDAQ:AIMD) a annoncé les résultats financiers du T3 2024 avec un chiffre d'affaires de zéro comparé à 24 489 $ au T3 2023. La société a enregistré une perte nette de 3,7 millions de dollars, en hausse par rapport à 3,0 millions de dollars au T3 2023. Les frais d'exploitation ont augmenté à 3,0 millions de dollars contre 2,6 millions de dollars, principalement en raison d'importants investissements en R&D. La position de trésorerie s'est renforcée à 5,2 millions de dollars au 30 septembre 2024.

Les développements clés incluent l'acquisition d'actifs de brevets multi-régionaux pour la technologie AI Nose, l'expansion du portefeuille de brevets VELDONA® pour les traitements contre le coronavirus, et le progrès des essais cliniques pour le syndrome de Sjögren et les verrues buccales liées au VIH. La plateforme AI Nose a atteint une précision de 79 % dans la détection des COV dans les usines de semi-conducteurs.

Ainos (NASDAQ:AIMD) hat die finanziellen Ergebnisse für das Q3 2024 veröffentlicht, mit null Einnahmen im Vergleich zu $24,489 im Q3 2023. Das Unternehmen meldete einen Nettoverlust von $3,7 Millionen, im Vergleich zu $3,0 Millionen im Q3 2023. Die Betriebskosten stiegen auf $3,0 Millionen von $2,6 Millionen, hauptsächlich aufgrund höherer Investitionen in Forschung und Entwicklung. Die Liquiditätsposition verbesserte sich auf $5,2 Millionen zum 30. September 2024.

Wichtige Entwicklungen umfassen die Sicherung von multi-regionalen Patenten für die AI Nose-Technologie, die Erweiterung des VELDONA®-Patentportfolios für Coronavirus-Behandlungen und den Fortschritt klinischer Studien für das Sjögren-Syndrom und HIV-bezogene orale Warzen. Die AI Nose-Plattform erzielte eine Genauigkeit von 79 % bei der Erkennung von VOCs in Halbleiterfabriken.

Positive
  • Secured 28 new multi-regional patent assets for AI Nose technology
  • AI Nose achieved 79% accuracy in detecting 22 different VOCs
  • Cash position increased to $5.2M from $1.9M at year-end 2023
  • Fully repaid convertible note financing from The Lind Partners
Negative
  • Revenue dropped to zero from $24,489 in Q3 2023
  • Net loss increased to $3.7M from $3.0M in Q3 2023
  • Operating expenses rose to $3.0M from $2.6M in Q3 2023
  • Negative gross profit of $547

Insights

The Q3 2024 results reveal concerning financial metrics. Revenue dropped to zero from $24,489 YoY, while operating expenses increased by 16.3% to $3.04M. R&D expenses grew significantly to $2.02M and net loss widened to $3.70M. The company's cash position improved to $5.16M, but burn rate remains high.

While strategic initiatives in AI Nose technology and VELDONA clinical trials show promise, the company's immediate financial performance is weak. The cessation of COVID-19 test kit sales has left a revenue vacuum and increased R&D spending suggests continued cash burn ahead. The full repayment of convertible notes is positive for the capital structure, but sustained losses without revenue generation raise sustainability concerns.

The advancement of VELDONA® clinical trials represents significant progress, particularly in rare diseases. The focus on Sjögren's syndrome and HIV-related oral warts targets unmet medical needs with market potential. The FDA orphan drug designation for HIV-related oral warts provides regulatory advantages and market exclusivity.

The AI Nose platform's 79% accuracy in VOC detection demonstrates promising technical capability. The expansion of patent protection for coronavirus treatments and securing 28 additional multi-regional patents strengthens the company's intellectual property portfolio. However, the timeline to revenue generation remains lengthy, with key human trials targeted for completion in 2026.

Secured multi-regional patent assets, strengthening Ainos' AI Nose technology.

Expanded VELDONA® patent portfolio with a new invention patent for treatments and preventions for coronavirus infections.

Progressed clinical trials for VELDONA®, including new studies on Sjögren's syndrome and HIV-related oral warts.

SAN DIEGO, CA / ACCESSWIRE / November 6, 2024 / Ainos, Inc. (NASDAQ:AIMD)(NASDAQ:AIMDW) ("Ainos", or the "Company"), an innovative healthcare company focused on advanced AI-driven point-of-care testing ("POCT") and low-dose interferon therapeutics, today announced its financial results for the third quarter ended September 30, 2024.

Chun-Hsien (Eddy) Tsai, Chairman of the Board, President, and Chief Executive Officer of Ainos, commented, "In Q3, we made significant strides in executing our strategic roadmap for advancing our VELDONA® and AI Nose platforms. In our VELDONA® human drug program, we are focusing on clinical trials for rare diseases that have few treatment options, such as HIV-related oral warts and Sjögren's syndrome. Both of these studies will commence in Taiwan. Our VELDONA animal drug initiatives have also gained momentum, as we continue to enroll subjects in a Taiwanese clinical study focused on feline chronic gingivostomatitis ("FCGS"), a cat oral infection. Furthermore, for VELDONA®, we expanded our intellectual properties portfolio with a new Taiwan patent for the treatment and prevention of coronavirus. Global patent protection has already been filed for this patent, underscoring our commitment to developing innovative, effective healthcare solutions."

"For our proprietary AI Nose platform, we obtained exclusive patent licenses from our strategic shareholder and product co-developer. These enhancements bolster our intellectual property in volatile organic compounds ("VOC") detection, fortifying our aim to digitize scent and eventually serve as AI's olfactory system. AI Nose has already demonstrated impressive capability beyond healthcare, reaching 79% accuracy in detecting 22 different VOCs in Japanese semiconductor factories."

"In the near-term, our focus remains on advancing our flagship VOC POCT candidate, Ainos Flora, alongside co-development programs. In Q4, we aim to commence a clinical study in Taiwan for the next-generation Ainos Flora and be ready for pilot production for our co-development initiatives. Additionally, we are committed to fully utilizing the VELDONA® platform to build a robust product portfolio addressing diverse therapeutic needs. Looking ahead, we remain dedicated to advancing our clinical studies, targeting the completion of two key human trials in 2026 while actively pursuing out-licensing opportunities for VELDONA® drug candidates."

Christopher Lee, Chief Financial Officer of Ainos, commented, "Throughout this period, we maintained prudent cost management while strategically prioritizing our R&D investments to drive long-term growth. I'm pleased to report the full repayment of the convertible note financing from The Lind Partners in Q3, highlighting our focus on disciplined capital management. Our higher operating expenses in Q3 were primarily driven by investments in R&D, demonstrating our commitment to progressing clinical trials and product development initiatives for VELDONA® and our AI Nose-powered POCTs. We are better capitalized compared to the same period last year. With healthy cash reserves and strong focus on cost-effective operations, we are well-positioned to support our growth initiatives and development milestones."

Third Quarter 2024 Financial Results

Revenues

Revenues were nominal in the third quarter of 2024, nil compared to US$24,489 in the same period of 2023. This decline reflects the Company's cessation of sales of its COVID-19 antigen rapid test kits after a strategic pivot shift and the sales returns that offset sales volume during the quarter.

Cost of Revenues

Cost of revenues was US$547 in the third quarter of 2024, compared to US$87,873 in the same period of 2023. The decrease was primarily attributable to the decrease in sales volume.

Gross Profit

In the third quarter of 2024, gross profit was negative US$547, narrowing from negative US$63,384 in the third quarter of 2023, due to lower sales volumes of the Company's newly launched products and reduced cost of revenues.

Total Operating Expenses

Total operating expenses were US$3,038,002 in the third quarter of 2024, compared to US$2,612,282 in the same period of 2023. The change was mainly attributable to increased expenses associated with co-research for technology, product and staffing expenditures, and increases in share-based compensation and professional expenses.

R&D expenses increased to US$2,022,244 in the third quarter of 2024 from US$1,710,265 in the same period of 2023. The increase was primarily due to increased expenses associated with co-research for technology and product, as well as staffing expenditures. Share-based compensation expenses and depreciation and amortization expenses in the third quarter of 2024 were US$1,305,461, compared with US$1,263,665 in the third quarter of 2023. Excluding these non-cash expenses, R&D expenses increased to US$716,783 from US$446,600 over the same period.

SG&A expenses increased to US$1,015,758 in the third quarter of 2024 from US$902,017 in the same period of 2023. Share-based compensation expenses and depreciation and amortization expenses in the third quarters of 2024 and 2023 were US$377,020 and US$269,934, respectively. Excluding these non-cash expenses, SG&A expenses mildly increased to US$638,738 from US$632,083 over the same period.

Net Loss

Net loss attributable to common stock shareholders was US$3,699,317 in the third quarter of 2024, compared to US$2,975,846 in the same period of 2023.

Balance Sheet

As of September 30, 2024, the Company had cash and cash equivalents of US$5,156,606, compared to US$1,885,628 as of December 31, 2023.

Recent Business Developments

On October 28, 2024, the Company secured exclusive licensing rights for an additional 28 multi-regional patent assets from our strategic shareholder and product co-developer. These patents encompass cutting-edge innovations in AI Nose gas sensing technology and extend Ainos' technological capabilities with a groundbreaking nitrogen-oxygen separation technology targeting medical applications.

On September 23, 2024, the Company announced its plans to conduct a clinical trial in Taiwan to evaluate VELDONA® for treating Sjögren's syndrome at Taipei Medical University-Shuang Ho Hospital. A total of eight clinical trials have been conducted in the U.S. and three Prior Phase 3 studies show positive benefits in increasing unstimulated whole saliva secretion without significant adverse effects.

On September 17, 2024, the Company announced its plans to initiate a clinical study for VELDONA® on treating HIV-related oral warts at the National Taiwan University Hospital (the "Hospital") to evaluate its efficacy. For this indication, VELDONA® has received orphan drug designation from the U.S. Food and Drug Administration ("FDA"). On September 25, 2024, Ainos received Institutional Review Board (IRB) approval from the Hospital for this clinical trial.

On September 3, 2024, the Company announced that it has secured an invention patent in Taiwan for VELDONA® formulation and has filed for global patent protection under the Patent Cooperation Treaty (PCT). This patent represents a significant milestone in the treatment and prevention of coronavirus infections.

On August 19, 2024, the Company said its AI Nose has made a key breakthrough in factory automation with 79% accuracy in detecting 761 samples across 22 different VOCs. This is a remarkable technological advancement in industrial manufacturing safety and smart manufacturing. Company also intends to explore integrating AI Nose into robots, enabling robots and humanoids to intelligently sense surroundings and better collaborate with human.

On August 9, 2024, the Company announced that it has obtained exclusive licenses from its strategic shareholder and product co-developer, bolstering both AI Nose and POCT. The newly licensed 10 invention patents and patent applications cover gas sensors and medical devices.

On August 6, 2024, the Company concluded its remaining convertible note financing from The Lind Partners, through conversions of the Note by the investor and payments by the Company.

About Ainos, Inc.

Headquartered in San Diego, California, Ainos is a diversified healthcare company focused on novel AI-powered point-of-care testing (POCT) and VELDONA low-dose interferon therapeutics. The Company's clinical-stage product pipeline includes VELDONA human and animal oral therapeutics, human orphan drugs, and telehealth-friendly POCT solutions powered by its AI Nose technology platform.

The name "Ainos" is a combination of "AI" and "Nose" to reflect the Company's commitment to empowering individuals to manage their health more effectively with next-generation AI-driven POCT solutions. To learn more, visit https://www.ainos.com.

Follow Ainos on X, formerly known as Twitter, (@AinosInc) and LinkedIn to stay up-to-date.

Safe Harbor Statements

Certain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements can be identified by the use of words such as "anticipate," "believe," "estimate," "approximate," "expect," "intend," "plan," "predict," "project," "target," "future," "likely," "strategy," "foresee," "may," "guidance," "potential," "outlook," "forecast," "should," "will" or other similar words or phrases. Similarly, statements that describe the Company's objectives, plans or goals are, or may be, forward-looking statements. Forward-looking statements are based only on the Company's current beliefs, expectations, and assumptions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. The Company's actual results may differ materially from those indicated in the forward-looking statements.

Important factors that could cause the Company's actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release include, among others, the cost of production and sales potential of the products announced in this press release; the Company's dependence on projected revenues from the sale of current or future products; the Company's limited cash and history of losses; the Company's ability to achieve profitability; the Company's ability to raise additional capital to continue the Company's product development; the ability to accurately predict the future operating results of the Company; the ability to advance Ainos' current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any product candidates the Company develops; the ability to obtain and maintain regulatory approval of Ainos' product candidates; delays in completing the development and commercialization of the Company's current and future product candidates, which could result in increased costs to the Company, delay or limit the ability to generate revenue and adversely affect the business, financial condition, results of operations and prospects of the Company; intense competition and rapidly advancing technology in the Company's industry that may outpace its technology; customer demand for the products and services the Company develops; the accuracy of third-party market research data, the impact of competitive or alternative products, technologies and pricing; disruption in research and development facilities; lawsuits and other claims by third parties or investigations by various regulatory agencies governing the Company's operations; potential cybersecurity attacks; increased requirements and costs related to cybersecurity; the Company's ability to realize the benefits of third party licensing agreements; the Company's ability to obtain and maintain intellectual property protection for Ainos product candidates; compliance with applicable laws, regulations and tariffs; continued listing on and compliance with the applicable regulations of the Nasdaq Capital Market; and the Company's success in managing growth. A more complete description of these risk factors and others is included in the "Risk Factors" section of Ainos' Annual Report on Form 10-K for the year ended December 31, 2023, and other public filings with the U.S. Securities and Exchange Commission ("SEC"), many of which risks are beyond the Company's control. In addition to the risks described above and in the Company's filings with the SEC, other unknown or unpredictable factors also could cause actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release.

The forward-looking statements made in this press release are expressly qualified in their entirety by the foregoing cautionary statements. Any forward-looking statements contained in this press release represent Ainos' views only as of today and should not be relied upon as representing its views as of any subsequent date. Ainos undertakes no obligation to, and expressly disclaims any such obligation to, publicly update or revise any forward-looking statement to reflect changed assumptions, the occurrence of anticipated or unanticipated events or changes to the future results over time or otherwise, except as required by law.

Investor Relations Contact

Feifei Shen
Email: IR@ainos.com

Ainos, Inc.
Condensed Balance Sheets
(Unaudited)

September 30,

December 31,

2024

2023

ASSETS

Current assets:

Cash and cash equivalents

$

5,156,606

$

1,885,628

Accounts receivable

-

455

Inventory, net

160,701

167,593

Other current asset

331,898

419,521

Total current assets

5,649,205

2,473,197

Intangible assets, net

24,888,249

28,283,208

Property and equipment, net

649,063

876,572

Other assets

183,229

208,827

Total assets

$

31,369,746

$

31,841,804

Liabilities and Stockholders' Equity

Current liabilities:

Contract liabilities

$

110,142

$

112,555

Convertible notes payable

3,000,000

-

Other notes payable, related party

270,000

42,000

Accrued expenses and others current liabilities

750,629

1,182,283

Total current liabilities

4,130,771

1,336,838

Senior secured convertible notes measured at fair value

-

2,651,556

Convertible notes payable - noncurrent

9,000,000

3,000,000

Other notes payable, related party - noncurrent

-

270,000

Other long-term liabilities

216,760

135,829

Total liabilities

13,347,531

7,394,223

Commitments and contingencies

Stockholders' equity:

Preferred stock, $0.01 par value; 50,000,000 shares authorized; none issued and outstanding

-

-

Common stock, $0.01 par value; 300,000,000 shares authorized as of September 30, 2024 and December 31, 2023, 13,813,434 and 4,677,787 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively

138,134

46,778

Common stock to be issued,900shares and 162,337 shares as of September 30, 2024 and December 31, 2023, respectively

9

1,623

Additional paid-in capital

66,223,783

62,555,808

Accumulated deficit

(48,095,304

)

(37,886,155

)

Accumulated other comprehensive loss - translation adjustment

(244,407

)

(270,473

)

Total stockholders' equity

18,022,215

24,447,581

Total liabilities and stockholders' equity

$

31,369,746

$

31,841,804

Ainos, Inc.
Condensed Statements of Operations
(Unaudited)

Three months ended September 30,

Nine months ended September 30,

2024

2023

2024

2023

Revenues

$

-

$

24,489

$

20,729

$

102,208

Cost of revenues

(547

)

(87,873

)

(52,674

)

(244,538

)

Gross loss

(547

)

(63,384

)

(31,945

)

(142,330

)

Operating expenses:

Research and development expenses

2,022,244

1,710,265

6,085,648

5,080,335

Selling, general and administrative expenses

1,015,758

902,017

3,090,056

2,282,631

Total operating expenses

3,038,002

2,612,282

9,175,704

7,362,966

Loss from operations

(3,038,549

)

(2,675,666

)

(9,207,649

)

(7,505,296

)

Non-operating (expenses) income, net:

Interest expense

(264,642

)

(44,267

)

(432,097

)

(93,852

)

Issuance cost of senior secured convertible note measured at fair value

(169,344

)

(260,967

)

(308,336

)

(260,967

)

Fair value change for senior secured convertible note

(177,212

)

-

(275,624

)

-

Other income, net

(49,570

)

5,054

14,557

14,067

Total non-operating expenses, net

(660,768

)

(300,180

)

(1,001,500

)

(340,752

)

Net loss before income taxes

(3,699,317

)

(2,975,846

)

(10,209,149

)

(7,846,048

)

Provision for income taxes

-

-

-

-

Net loss

$

(3,699,317

)

$

(2,975,846

)

$

(10,209,149

)

$

(7,846,048

)

SOURCE: Ainos, Inc.



View the original press release on accesswire.com

FAQ

What was Ainos (AIMD) revenue in Q3 2024?

Ainos reported zero revenue in Q3 2024, compared to $24,489 in Q3 2023.

How much cash did Ainos (AIMD) have as of September 30, 2024?

Ainos had cash and cash equivalents of $5,156,606 as of September 30, 2024.

What was the accuracy rate of Ainos (AIMD) AI Nose technology in Q3 2024?

Ainos' AI Nose achieved 79% accuracy in detecting 761 samples across 22 different VOCs in semiconductor factories.

What clinical trials did Ainos (AIMD) announce in Q3 2024?

Ainos announced clinical trials for VELDONA® to treat Sjögren's syndrome at Taipei Medical University-Shuang Ho Hospital and HIV-related oral warts at National Taiwan University Hospital.

Ainos, Inc.

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