Scinai Publishes Financial Results and Provides Business Update; Shareholders' Equity up from negative $7.3 million as of June 30, 2024, to positive $10 million
Scinai Immunotherapeutics (NASDAQ: SCNI) reported financial results for the nine months ended September 30, 2024. The company's shareholders' equity improved to positive $10 million from negative $7.3 million, primarily due to the conversion of a EUR 26.6 million EIB loan into preferred shares. Revenue reached $452,000, compared to no revenues in the same period of 2023. The company reported a net gain of $7,026,000 versus a net loss of $4,170,000 in the previous year. Cash position decreased to $1,169,000 from $5,010,000. The CDMO business unit received work orders valued at approximately $600,000 and expects material revenue growth in coming years.
Scinai Immunotherapeutics (NASDAQ: SCNI) ha riportato risultati finanziari per i nove mesi terminati il 30 settembre 2024. Il patrimonio netto della società è migliorato a un positivo $10 milioni rispetto a un negativo $7,3 milioni, principalmente a causa della conversione di un prestito EIB di 26,6 milioni di euro in azioni privilegiate. I ricavi hanno raggiunto $452,000, contro nessun incasso nello stesso periodo del 2023. La società ha riportato un guadagno netto di $7,026,000 rispetto a una perdita netta di $4,170,000 nell'anno precedente. La posizione di cassa è diminuita a $1,169,000 rispetto a $5,010,000. L'unità di business CDMO ha ricevuto ordini di lavoro per un valore di circa $600,000 e prevede una crescita significativa dei ricavi nei prossimi anni.
Scinai Immunotherapeutics (NASDAQ: SCNI) reportó resultados financieros para los nueve meses terminados el 30 de septiembre de 2024. El patrimonio neto de la empresa mejoró a un positivo $10 millones desde un negativo $7.3 millones, principalmente debido a la conversión de un préstamo del BEI de 26.6 millones de euros en acciones preferentes. Los ingresos alcanzaron $452,000, en comparación con ningún ingreso en el mismo período de 2023. La empresa reportó una ganancia neta de $7,026,000 frente a una pérdida neta de $4,170,000 en el año anterior. La posición de efectivo disminuyó a $1,169,000 desde $5,010,000. La unidad de negocio CDMO recibió órdenes de trabajo valoradas en aproximadamente $600,000 y espera un crecimiento significativo de ingresos en los próximos años.
Scinai Immunotherapeutics (NASDAQ: SCNI)는 2024년 9월 30일 종료된 9개월 동안의 재무 결과를 보고했습니다. 회사의 자본금이 -730만 달러에서 1000만 달러로 개선되었습니다. 이는 EIB의 2,660만 유로 대출을 우선주로 전환한 데 주로 기인합니다. 수익은 $452,000에 도달했으며, 2023년 같은 기간에는 수익이 없었습니다. 회사는 이전 연도에 비해 $7,026,000의 순이익을 보고했으며, 지난해에는 $4,170,000의 순손실을 기록했습니다. 현금 보유액은 $5,010,000에서 $1,169,000로 감소했습니다. CDMO 사업부는 약 $600,000 상당의 작업 주문을 받았으며, 향후 몇 년 동안 실질적인 수익 성장을 예상하고 있습니다.
Scinai Immunotherapeutics (NASDAQ: SCNI) a rapporté des résultats financiers pour les neuf mois se terminant le 30 septembre 2024. Les capitaux propres de la société se sont améliorés à un montant positif de 10 millions de dollars contre un montant négatif de 7,3 millions de dollars, principalement en raison de la conversion d'un prêt de 26,6 millions d'euros de la BEI en actions privilégiées. Les revenus ont atteint 452,000 $, contre aucun revenu pour la même période de 2023. La société a rapporté un gain net de 7,026,000 $ par rapport à une perte nette de 4,170,000 $ l'année précédente. La position de trésorerie a diminué à 1,169,000 $ contre 5,010,000 $. L'unité commerciale CDMO a reçu des commandes de travail d'une valeur d'environ 600,000 $ et s'attend à une croissance significative des revenus dans les années à venir.
Scinai Immunotherapeutics (NASDAQ: SCNI) hat die finanziellen Ergebnisse für die neun Monate bis zum 30. September 2024 veröffentlicht. Das Eigenkapital des Unternehmens verbesserte sich auf positive $10 Millionen, gegenüber einem negativen $7,3 Millionen, was hauptsächlich auf die Umwandlung eines EIB-Darlehens in Höhe von 26,6 Millionen Euro in Vorzugsaktien zurückzuführen ist. Der Umsatz erreichte $452,000, verglichen mit keinen Einnahmen im gleichen Zeitraum 2023. Das Unternehmen berichtete von einem Nettoergebnis von $7,026,000 im Vergleich zu einem Nettoverlust von $4,170,000 im Vorjahreszeitraum. Die Liquiditätsposition verringerte sich auf $1,169,000 von $5,010,000. Die CDMO-Geschäftseinheit erhielt Arbeitsaufträge im Wert von etwa $600,000 und erwartet in den kommenden Jahren ein erhebliches Umsatzwachstum.
- Shareholders' equity improved to positive $10 million from negative $7.3 million
- First-time revenue generation of $452,000 from CDMO business
- Net gain of $7,026,000 compared to previous year's loss
- Reduction of marketing and administrative expenses by 46.5% to $1,767,000
- Secured $600,000 in CDMO work orders for 2024
- Cash position declined 76.7% to $1,169,000 from $5,010,000
- Gross loss of $413,000 from CDMO operations
- Operating loss of $6,375,000 for the nine-month period
Insights
The financial results reveal significant improvements in Scinai's balance sheet position. The conversion of the
The CDMO business unit shows early traction with
The company's strategic pivot to inflammation and immunology shows promising progress with their anti-IL-17A/F nanoAb program. The positive regulatory feedback from PEI and successful pre-clinical results in plaque psoriasis indicate a clear path to Phase 1/2a trials expected in H2 2025. The intralesional delivery approach for mild to moderate psoriasis represents an innovative market positioning.
The licensing agreement with an unnamed U.S. company for certain patents demonstrates early validation of their technology platform. The additional nanoAbs pipeline for asthma, atopic dermatitis and wet AMD provides multiple shots on goal. However, the company's ability to advance these programs will depend heavily on securing additional funding or strategic partnerships given the current cash position.
Business Update & Recent Highlights
Conversion of EIB Loan into Equity bringing shareholders' equity to
On August 21, 2024, the Company announced that it had closed a Loan Restructuring Agreement, which included an amendment and restatement to the amended Finance Contract with the European Investment Bank (the "EIB"). In connection with the transaction, an amount equal to approximately EUR 26.6 million (equal to approximately
Following the conversion, the total outstanding amount owed by the Company to the EIB was reduced to
On August 29, 2024, the Company announced that on August 27, 2024, it had received formal notification from the Listing Qualification Department of the Nasdaq Stock Market that the Company had regained compliance with Nasdaq Listing Rule 5550(b)(1) (the "Rule") that requires listed companies to maintain stockholders' equity of at least
CDMO business unit
Since Jan 2024, the Company has received CDMO work orders valued at approximately
In addition, in 2024 the Company has been pursuing extensive targeted marketing activities, including online advertisements, direct outreach campaigns and participation in major pharmaceutical conferences, such as BIO Europe Spring in
The Company's CDMO unit is currently focused both on executing drug development projects for its clients and on validating its processes and facilities as required by cGMP standards.
R&D business unit - Pipeline Development
On June 4, 2024, the Company met for a scientific advisory meeting with the Paul Erlich Institute (the PEI) of
On July 15, 2024, the Company announced promising results from its pre-clinical, in-vivo proof of concept study in plaque psoriasis, conducted by the team of Prof. Amos Gilhar at the internationally renowned Skin Research Laboratory at the Technion, Israel Institute of Technology,
Additional nanoAbs for treatment of additional autoimmune diseases, such as asthma, atopic dermatitis and wet AMD, have been discovered and characterized at the Max Planck Institute in Gottingen and the University Medical Center Göttingen, both in
The Company is pursuing strategic partnerships and sublicensing options for its anti-IL-17 nanoAb for the treatment of plaque psoriasis and other potential indications and also is looking for partners to co-develop or sub license the additional nanoAbs that have been discovered and characterized. Parties interested in discussing partnering opportunities should contact the company at BD@scinai.com
Nine (9) Months of 2024 Financial Summary
- Revenues for the nine months ended September 30, 2024, amounted to
$452 thousands
The increase is due to the CDMO starting to generate revenues for the first time in 2024. - R&D expenses for the nine months ended September 30, 2024, amounted to
$4,195 thousands $4,583 thousands - Marketing, general and administrative expenses for the nine months ended September 30, 2024, amounted to
$1,767 thousands $3,300 thousands - Financial income, net for the nine months ended September 30, 2024, amounted to
$13,374 thousands $3,713 thousands $14,759 - Net Gain for the nine months ended September 30, 2024, was
$7,026 thousands $4,170 thousands $14,759
As of September 30, 2024, Scinai had cash and cash equivalents and short-term deposits of
SCINAI IMMUNOTHERAPEUTICS LTD.
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(Formerly known as BiondVax Pharmaceuticals Ltd.)
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CONDENSED FINANCIAL STATEMENTS
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September 30, 2024 | ||||||||
Unaudited
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SCINAI IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals Ltd.) – (Unaudited)
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BALANCE SHEETS | ||||||||
September 30, | December 31, | |||||||
2024 | 2023 | |||||||
ASSETS | ||||||||
CURRENT ASSETS: | ||||||||
Cash and cash equivalents | $ | 1,032 | $ | 4,870 | ||||
Restricted cash | 137 | 140 | ||||||
Trade receivables | 120 | - | ||||||
Prepaid expenses and other receivables | 328 | 437 | ||||||
Total current assets | 1,617 | 5,447 | ||||||
NON-CURRENT ASSETS: | ||||||||
Property, plant and equipment, net | 9,686 | 10,825 | ||||||
Operating lease right-of-use assets | 958 | 1,200 | ||||||
Total non-current assets | 10,644 | 12,025 | ||||||
Total assets | $ | 12,261 | $ | 17,472 | ||||
The accompanying notes are an integral part of the financial statements. | ||||||||
SCINAI IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals Ltd.) – (Unaudited)
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BALANCE SHEETS | ||||||||
September 30, | December 31, | |||||||
2024 | 2023 | |||||||
LIABILITIES NET OF CAPITAL DEFICIENCY | ||||||||
CURRENT LIABILITIES: | ||||||||
Trade payables | $ | 430 | $ | 535 | ||||
Operating lease liabilities | 364 | 396 | ||||||
Other payables | 598 | 849 | ||||||
Total current liabilities | 1,392 | 1,780 | ||||||
NON-CURRENT LIABILITIES: | ||||||||
Warrants liability | 3 | 96 | ||||||
Loan from others | 280 | 19,368 | ||||||
Non-current operating lease liabilities | 583 | 797 | ||||||
Total non-current liabilities | 866 | 20,261 | ||||||
SHAREHOLDERS' DEFICIT: | ||||||||
Ordinary shares of no-par value: Authorized: 20,000,000,000 shares at September 30, 2024 and at December 31, 2023; Issued and outstanding 3,411,983,584 shares at September 30, 2024 and 1,857,169,984 shares at December 31, 2023 | - | - | ||||||
Preferred shares, no par value; Authorized: 1,000 shares at September 30, 2024 and 0 shares at December 31, 2023; Issued and outstanding: 1,000 shares at September 30, 2024 and 0 shares at December 31, 2023 | 5,627 | - | ||||||
Additional paid-in capital | 121,425 | 119,506 | ||||||
Accumulated deficit | (115,309) | (122,335) | ||||||
Accumulated other comprehensive loss | (1,740) | (1,740) | ||||||
Total shareholders' equity (deficit) | 10,003 | (4,569) | ||||||
Total liabilities and shareholders' equity (deficit) | $ | 12,261 | $ | 17,472 | ||||
SCINAI IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals Ltd.) – (Unaudited) | ||||||||||||
STATEMENTS OF OPERATIONS | ||||||||||||
For the Three months ended | For the Nine months ended | |||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||
Unaudited | ||||||||||||
Revenues | $ | 168 | - | $ | 452 | - | ||||||
Cost of revenues | (417) | - | (865) | - | ||||||||
Gross loss | (249) | - | (413) | |||||||||
Research and development expenses, net | $ | (1,407) | $ | (1,134) | $ | (4,195) | $ | (4,583) | ||||
Marketing, general and administrative | (764) | (968) | (1,767) | (3,300) | ||||||||
Total operating expenses | (2,171) | (2,102) | (5,962) | (7,883) | ||||||||
Total operating loss | (2,420) | (2,102) | (6,375) | (7,883) | ||||||||
Financial income from loan conversion | 14,759 | - | 14,759 | - | ||||||||
Other Financial income, (expenses) net | (1,884) | (5,209) | (1,385) | 3,713 | ||||||||
Financial income (loss), net | 12,875 | (5,209) | 13,374 | 3,713 | ||||||||
Net gain (loss) | $ | 10,455 | $ | (3,107) | $ | 7,026 | $ | (4,170) | ||||
Net gain (loss) per share attributable to basic ordinary shareholders, | 0.0021 | (0.002) | 0.0026 | (0.002) | ||||||||
Weighted average number of shares used for computing basic net loss per share | 3,374,265,323 | 1,876,885,253 | 2,652,916,244 | 1,682,990,012 | ||||||||
SCINAI IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals Ltd.) – (Unaudited) | ||||||||||
STATEMENTS OF COMPREHENSIVE LOSS | ||||||||||
For the Three months ended September 30, | For the Nine months ended September 30, | |||||||||
2024 | 2023 | 2024 | 2023 | |||||||
Net gain (loss) | $ | 10,455 | $ | (3,107) | $ | 7,026 | $ | (4,170) | ||
Other comprehensive income: | - | - | - | - | ||||||
Foreign currency translation adjustments | - | - | - | 267 | ||||||
Total comprehensive gain (loss) | $ | 10,455 | $ | (3,107) | $ | 7,026 | $ | (3,903) | ||
SCINAI IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals Ltd.) – (Unaudited)
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STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY | |||||||||||||||||||||||||||||||||||||||||||||||||||
Ordinary shares | Preferred shares | Additional paid-in | Accumulated comprehensive | Accumulated | Total shareholders' | ||||||||||||||||||||||||||||||||||||||||||||||
Number | Amount | Number | Amount | capital | loss | deficit | equity | ||||||||||||||||||||||||||||||||||||||||||||
Balance as of January 1, 2024 | 1,857,169,984 | $ | - | - | $ | - | $ | 119,506 | $ (1, 740 | ) | $ | (122,335 | ) | $ | (4,569) | ||||||||||||||||||||||||||||||||||||
Issuance and exercise of warrants, net of issuance costs of |
1,553,792,800 |
- |
1,441 |
- |
- |
1,441 | |||||||||||||||||||||||||||||||||||||||||||||
Loan conversion into preferred shares |
- |
- |
1,000 |
5,627 |
- |
- |
- |
5,627 | |||||||||||||||||||||||||||||||||||||||||||
Vested RSU's | 1,020,800 | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||
Share-based compensation | - | - | 478 | - | - | 478 | |||||||||||||||||||||||||||||||||||||||||||||
Net gain | - | - | - | - | 7,026 | 7,026 | |||||||||||||||||||||||||||||||||||||||||||||
Balance as of September 30, 2024 | 3,411,983,584 | - | 1,000 | $ | 5,627 | $ | 121,425 | $ (1, 740) | $ | (115,309) | $ | 10,003 | |||||||||||||||||||||||||||||||||||||||
Nine months ended September 30, 2023 | ||||||||||||||||||
Ordinary shares | Additional paid-in | Accumulated | Accumulated | Total shareholders' | ||||||||||||||
Number | Amount | capital | comprehensive loss | deficit | equity | |||||||||||||
Balance as of January 1, 2023 | 989,290,784 | $ - | $ 116,082 | $ (2,007) | $ (115,835) | $ (1,760) | ||||||||||||
Exercise of warrants | 584,015,200 | - | 801 | - | - | 801 | ||||||||||||
Vested RSU's | 7,464,800 | - | - | - | - | - | ||||||||||||
Issuance of shares and warrants, net | 160,000,000 | 1,484 | 1,484 | |||||||||||||||
Share-based compensation | - | - | 686 | - | - | 686 | ||||||||||||
Other comprehensive income | - | - | - | 267 | - | 267 | ||||||||||||
Net loss | - | - | - | - | (4,170) | (4,170) | ||||||||||||
Balance as of September 30, 2023 | 1,740,770,784 | - $ | $ (2,692) | |||||||||||||||
SCINAI IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals Ltd.) – (Unaudited)
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STATEMENTS OF CASH FLOWS | ||||||||
U.S. dollars in thousands | ||||||||
For the nine months ended | ||||||||
2024 | 2023 | |||||||
Cash flows from operating activities: | ||||||||
Net gain (loss) | $ | 7,026 | $ | (4,170) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation of property, plant and equipment | 1,150 | 430 | ||||||
Financial expense (income) related to loan from others | 1,302 | (369) | ||||||
Financial income related to loan conversion | (14,759) | - | ||||||
Revaluation of warrants | (93) | (3,924) | ||||||
Share-based compensation | 478 | 686 | ||||||
Increase in trade receivables | (120) | - | ||||||
Decrease (increase) in other receivables | 109 | (82) | ||||||
Changes in operating lease right-of-use assets | 246 | (14) | ||||||
Increase in trade payables | (102) | (135) | ||||||
Changes in operating lease liabilities | (246) | - | ||||||
Increase (decrease) in other payables | (250) | (579) | ||||||
Net cash used in operating activities | (5,259) | (8,157) | ||||||
Cash flows from investing activities: | ||||||||
Purchase of property, plant and equipment | (12) | (403) | ||||||
Net cash used in investing activities | $ | (12) | $ | (403) | ||||
SCINAI IMMUNOTHERAPEUTICS LTD. (Formerly known as BiondVax Pharmaceuticals Ltd.) – (Unaudited)
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STATEMENTS OF CASH FLOWS | |||||||||
For the nine months ended September 30, | |||||||||
2024 | 2023 | ||||||||
Cash flows from financing activities: | |||||||||
Issuance of shares and warrants | - | 1,086 | |||||||
Proceed from exercise of warrants, net | $ | 1,441 | - | ||||||
Net cash provided by financing activities | 1,441 | 1,086 | |||||||
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (11) | (258) | |||||||
Increase (decrease) in cash, cash equivalents and restricted cash | (3,841) | (7,732) | |||||||
Cash, cash equivalents and restricted cash at beginning of year | 5,010 | 14,215 | |||||||
Cash, cash equivalents and restricted cash at end of year | $ | 1,169 | $ | 6,484 | |||||
Supplementary disclosure of cash flows activities: | |||||||||
(1) Cash paid during the year for: | |||||||||
Interest | $ | 143 | $ | 725 | |||||
(2) Non-cash transactions: | |||||||||
Issuance of warrants | - | 1,345 | |||||||
Loan convert into preferred shares | 5,627 | - | |||||||
Exercise of warrants liability into shares | $ | - | $ | 801 | |||||
Reconciliation of cash, cash equivalents and restricted cash: | |||||||||
Cash and cash equivalents | $ | 1,032 | $ | 6,362 | |||||
Restricted cash | 137 | 122 | |||||||
Cash, cash equivalents and restricted cash | $ | 1,169 | $ | 6,484 | |||||
About Scinai Immunotherapeutics
Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) is a biopharmaceutical company with two complementary business units, one focused on in-house development of inflammation and immunology (I&I) biological therapeutic products beginning with an innovative, de-risked pipeline of nanosized VHH antibodies (nanoAbs) targeting diseases with large unmet medical needs, and the other a boutique CDMO providing biological drug development, analytical methods development, clinical cGMP manufacturing, and pre-clinical and clinical trial design and execution services for early stage biotech drug development projects.
Company website: www.scinai.com.
Company Contacts
Investor Relations | +972 8 930 2529 | ir@scinai.com
Business Development | +972 8 930 2529 | bd@scinai.com
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. All statements, other than statements of historical facts, are forward-looking statements. Examples of such statements include, but are not limited to, the potential of Scinai's nanoAb program, expected revenues of Scinai's CDMO business and timing of pre-clinical and clinical studies of the Company's anti-IL nanoAbs for the treatment of plaque psoriasis and their results. These forward-looking statements reflect management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of Scinai Immunotherapeutics Ltd. Risks and uncertainties include, but are not limited to; the risk that the Company will otherwise be unable to remain compliant with the continued listing requirements of Nasdaq; lower than anticipated revenues of Scinai's CDMO business in 2024 and thereafter; failure to sign agreements with other potential clients of the CDMO business; a delay in the commencement and results of pre-clinical and clinical studies, including the Phase 1/2a study for psoriasis, the risk of delay in, Scinai's inability to conduct, or the unsuccessful results of, its research and development activities, including the contemplated in-vivo studies and a clinical trial; the risk that Scinai will not be successful in expanding its CDMO business or in-license other nanoAbs; the risk that Scinai may not be able to secure additional capital on attractive terms, if at all; the risk that the therapeutic and commercial potential of nanoAbs will not be met or that Scinai will not be successful in bringing the nanoAbs towards commercialization; the risk of a delay in the preclinical and clinical trials data for nanoAbs, if any; the risk that our business strategy may not be successful; Scinai's ability to acquire rights to additional product opportunities; Scinai's ability to enter into collaborations on terms acceptable to Scinai or at all; timing of receipt of regulatory approval of Scinai's manufacturing facility in
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FAQ
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