Phio Pharmaceuticals Reports 2024 Year End Financial Results and Provides Business Update
Phio Pharmaceuticals (NASDAQ: PHIO) reported its 2024 financial results and provided updates on its PH-762 clinical trial progress. The company's Phase 1b trial for PH-762, treating cutaneous carcinomas through intratumoral injection, showed promising results with 2 complete responses and 1 partial response in the second cohort. The third cohort is fully enrolled, with study completion expected in Q3 2025.
Financial highlights include raising $9.2 million through offerings and $2.9 million from warrant exercises. The company reported cash position of $5.4 million as of December 31, 2024, with net loss decreasing to $7.2 million ($9.08 per share) from $10.8 million in 2023. Research and development expenses decreased by 42% to $2.7 million, while general and administrative expenses reduced by 14% to $3.7 million.
The company implemented cost rationalization measures, including relocating to a smaller facility and terminating its Clinical Co-Development Agreement with AgonOx. Phio's patent portfolio includes 77 issued patents, with 69 covering its INTASYL technology.
Phio Pharmaceuticals (NASDAQ: PHIO) ha riportato i risultati finanziari per il 2024 e ha fornito aggiornamenti sui progressi del suo trial clinico PH-762. Il trial di Fase 1b per PH-762, che tratta i carcinomi cutanei attraverso iniezioni intratumorali, ha mostrato risultati promettenti con 2 risposte complete e 1 risposta parziale nel secondo gruppo. Il terzo gruppo è completamente arruolato, con il completamento dello studio previsto per il terzo trimestre del 2025.
I punti salienti finanziari includono la raccolta di 9,2 milioni di dollari attraverso offerte e 2,9 milioni di dollari da esercizi di warrant. L'azienda ha riportato una posizione di cassa di 5,4 milioni di dollari al 31 dicembre 2024, con una perdita netta che è diminuita a 7,2 milioni di dollari (9,08 dollari per azione) rispetto ai 10,8 milioni di dollari del 2023. Le spese per ricerca e sviluppo sono diminuite del 42% a 2,7 milioni di dollari, mentre le spese generali e amministrative sono state ridotte del 14% a 3,7 milioni di dollari.
L'azienda ha implementato misure di razionalizzazione dei costi, inclusi il trasferimento in una struttura più piccola e la risoluzione del suo Accordo di Co-Sviluppo Clinico con AgonOx. Il portafoglio brevetti di Phio include 77 brevetti rilasciati, di cui 69 coprono la sua tecnologia INTASYL.
Phio Pharmaceuticals (NASDAQ: PHIO) informó sobre sus resultados financieros de 2024 y proporcionó actualizaciones sobre el progreso de su ensayo clínico PH-762. El ensayo de Fase 1b para PH-762, que trata carcinomas cutáneos a través de inyecciones intratumorales, mostró resultados prometedores con 2 respuestas completas y 1 respuesta parcial en el segundo grupo. El tercer grupo está completamente inscrito, y se espera que el estudio finalice en el tercer trimestre de 2025.
Los aspectos financieros destacados incluyen la recaudación de 9,2 millones de dólares a través de ofertas y 2,9 millones de dólares por ejercicios de warrants. La compañía reportó una posición de efectivo de 5,4 millones de dólares al 31 de diciembre de 2024, con una pérdida neta que disminuyó a 7,2 millones de dólares (9,08 dólares por acción) desde 10,8 millones de dólares en 2023. Los gastos en investigación y desarrollo disminuyeron un 42% a 2,7 millones de dólares, mientras que los gastos generales y administrativos se redujeron en un 14% a 3,7 millones de dólares.
La empresa implementó medidas de racionalización de costos, incluyendo el traslado a una instalación más pequeña y la terminación de su Acuerdo de Co-Desarrollo Clínico con AgonOx. El portafolio de patentes de Phio incluye 77 patentes emitidas, de las cuales 69 cubren su tecnología INTASYL.
Phio Pharmaceuticals (NASDAQ: PHIO)는 2024년 재무 결과를 보고하고 PH-762 임상 시험 진행 상황에 대한 업데이트를 제공했습니다. PH-762의 1b 단계 시험은 종양 내 주사를 통해 피부 암을 치료하며, 두 번째 집단에서 2건의 완전 반응과 1건의 부분 반응을 보여주었습니다. 세 번째 집단은 완전히 등록되었으며, 연구 완료는 2025년 3분기로 예상됩니다.
재무 하이라이트에는 920만 달러의 자금 조달과 290만 달러의 워런트 행사로 모금한 내용이 포함되어 있습니다. 회사는 2024년 12월 31일 기준으로 540만 달러의 현금 보유액을 보고했으며, 순손실은 2023년의 1080만 달러에서 720만 달러(주당 9.08달러)로 감소했습니다. 연구 및 개발 비용은 42% 감소하여 270만 달러가 되었고, 일반 및 관리 비용은 14% 감소하여 370만 달러가 되었습니다.
회사는 비용 합리화 조치를 시행했으며, 여기에는 더 작은 시설로 이전하고 AgonOx와의 임상 공동 개발 계약을 종료하는 것이 포함됩니다. Phio의 특허 포트폴리오는 77개의 발급된 특허를 포함하고 있으며, 그 중 69개는 INTASYL 기술을 다룹니다.
Phio Pharmaceuticals (NASDAQ: PHIO) a publié ses résultats financiers pour 2024 et a fourni des mises à jour sur l'avancement de son essai clinique PH-762. L'essai de Phase 1b pour PH-762, qui traite les carcinomes cutanés par injection intratumorale, a montré des résultats prometteurs avec 2 réponses complètes et 1 réponse partielle dans la deuxième cohorte. La troisième cohorte est entièrement inscrite, et l'achèvement de l'étude est prévu pour le troisième trimestre 2025.
Les points saillants financiers incluent la collecte de 9,2 millions de dollars par le biais d'offres et de 2,9 millions de dollars provenant de l'exercice de bons de souscription. L'entreprise a déclaré une position de trésorerie de 5,4 millions de dollars au 31 décembre 2024, avec une perte nette diminuant à 7,2 millions de dollars (9,08 dollars par action) contre 10,8 millions de dollars en 2023. Les dépenses de recherche et développement ont diminué de 42 % pour atteindre 2,7 millions de dollars, tandis que les dépenses générales et administratives ont été réduites de 14 % à 3,7 millions de dollars.
L'entreprise a mis en œuvre des mesures de rationalisation des coûts, notamment le déménagement dans des locaux plus petits et la résiliation de son Accord de Co-Développement Clinique avec AgonOx. Le portefeuille de brevets de Phio comprend 77 brevets délivrés, dont 69 couvrent sa technologie INTASYL.
Phio Pharmaceuticals (NASDAQ: PHIO) hat seine finanziellen Ergebnisse für 2024 veröffentlicht und Updates zum Fortschritt der PH-762 klinischen Studie bereitgestellt. Die Phase 1b Studie für PH-762, die kutane Karzinome durch intratumorale Injektion behandelt, zeigte vielversprechende Ergebnisse mit 2 vollständigen und 1 teilweisen Ansprechreaktion in der zweiten Kohorte. Die dritte Kohorte ist vollständig eingeschrieben, und der Abschluss der Studie wird für das dritte Quartal 2025 erwartet.
Zu den finanziellen Highlights gehört die Beschaffung von 9,2 Millionen Dollar durch Angebote und 2,9 Millionen Dollar aus der Ausübung von Warrants. Das Unternehmen berichtete über eine Liquiditätsposition von 5,4 Millionen Dollar zum 31. Dezember 2024, wobei der Nettoverlust auf 7,2 Millionen Dollar (9,08 Dollar pro Aktie) von 10,8 Millionen Dollar im Jahr 2023 gesenkt wurde. Die Forschungs- und Entwicklungskosten sanken um 42% auf 2,7 Millionen Dollar, während die allgemeinen und administrativen Kosten um 14% auf 3,7 Millionen Dollar reduziert wurden.
Das Unternehmen hat Kostensenkungsmaßnahmen umgesetzt, einschließlich des Umzugs in eine kleinere Einrichtung und der Beendigung seiner klinischen Co-Entwicklungsvereinbarung mit AgonOx. Das Patentportfolio von Phio umfasst 77 erteilte Patente, von denen 69 seine INTASYL-Technologie abdecken.
- Promising clinical results with 2 complete responses and 1 partial response in second cohort
- Successfully raised $12.1 million through offerings and warrant exercises
- Reduced net loss by 33% year-over-year
- Decreased R&D expenses by 42% through cost rationalization
- Strong patent portfolio with 77 issued patents
- Continued net loss of $7.2 million in 2024
- Cash position decreased to $5.4 million from $8.5 million year-over-year
- Terminated Clinical Co-Development Agreement with AgonOx due to enrollment delays
- Reduced research capabilities due to downsizing facilities
Insights
The clinical progress of Phio's lead candidate PH-762 represents the most important aspect of this release. The Phase 1b trial has shown promising early efficacy signals - with 2 complete responses (100% tumor clearance) and 1 partial response (90% tumor clearance) among the 4 patients in the second cohort. All were diagnosed with cutaneous squamous cell carcinoma. First cohort patients maintained stable disease.
Importantly, PH-762's safety profile appears favorable, with no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects reported across all treated patients. The Safety Monitoring Committee has twice recommended dose escalation, indicating a manageable safety profile.
The third cohort is now fully enrolled with patients in treatment or follow-up. The company expects to complete overall trial enrollment by Q3 2025. The termination of their co-development agreement with AgonOx represents a strategic decision to focus resources on their self-directed trial rather than suggesting any efficacy concerns - notably, the single patient treated with the combination therapy showed tumor reductions of 65%, 100%, and 81% in three melanoma lesions.
For an early-stage oncology asset, these preliminary signals of both efficacy and tolerability are encouraging, though the small patient population necessitates caution in interpretation. The continued advancement through dose cohorts without safety issues is a positive sign for this novel siRNA approach targeting cutaneous malignancies.
Phio's financial position reflects a company making strategic adjustments to extend runway while advancing clinical programs. The net loss decreased to
The company has successfully strengthened its balance sheet, raising gross proceeds of approximately
The cost rationalization program implemented in 2023 shows tangible results - Phio downsized its facilities footprint from Marlborough to a smaller research space in Worcester, reduced headcount, and decreased clinical consulting fees by approximately
While the year-end cash position of
Continues advancing clinical trial for INSTASYL siRNA lead product candidate PH-762
3rd Cohort now fully enrolled in on-going clinical study
Marlborough, Massachusetts--(Newsfile Corp. - March 31, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company developing therapeutics that use its INTASYL® siRNA gene silencing technology designed to make the body's immune cells more effective in killing cancer cells. Phio today reported its financial results for the year ended December 31, 2024, and provided a business update.
Recent Corporate Updates
PH-762 Clinical Progress
PH-762 is currently being evaluated in a U.S. multi-center Phase 1b dose-escalating clinical trial through the intratumoral injection of PH-762 for the treatment of patients with cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. The trial (NCT 06014086) is designed to evaluate the safety and tolerability of neoadjuvant use of intratumorally injected PH-762 in up to 30 patients to assess tumor response and determine the dose or dose range for continued study of PH-762 in future trials. In May and December 2024, respectively, a Safety Monitoring Committee (SMC) reviewed data from the first and second dose cohorts treated with PH-762, and in both instances recommended escalation to the next dose concentration. A total of 7 patients with cutaneous carcinomas have been enrolled in dose cohorts 1 and 2. The second cohort enrolled a total of 4 patients, all of whom were diagnosed with cutaneous squamous cell carcinoma. At Day 36 (tumor excision), a complete response (
To date, intratumoral injection of PH-762 has been well tolerated in all enrolled patients. There were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in the patients receiving intratumoral PH-762. The third dose cohort is fully enrolled and patients in this cohort are currently in the treatment or follow-up phase of the study. Phio expects to complete enrollment of all patients in the study in the third quarter of 2025.
Capital Sourcing
In December 2024 and January 2025, Phio raised an aggregate of approximately
Cost Rationalization
In 2023, Phio commenced a cost rationalization program resulting from its strategy to transition from discovery research to a product development focus. In combination with headcount reductions, Phio did not renew its building lease in Marlborough, MA., the lease for which expired on March 31, 2024. The Company has established a smaller research footprint in the Massachusetts Biomedical Initiatives in Worcester, MA, where the Company leases laboratory space. Expense reductions have been redirected to funding the Phase 1b clinical trial for PH-762.
In May 2024, Phio terminated its Clinical Co-Development Agreement with AgonOx, Inc. (AgonOx). The Clinical Co-Development Agreement was entered into to conduct a Phase 1 clinical trial of PH-762 in combination with Agonox's "double positive" tumor infiltrating lymphocytes (DP TIL) in patients with advanced melanoma and other advanced solid tumors. The primary trial objectives were to evaluate the safety and to study the potential for enhanced therapeutic benefit from the administration of PH-762 treated DP TIL. AgonOx had enrolled three patients. The first two patients were treated with DP TIL only, and a third patient was treated with a combination of DP TIL and PH-762. Clinical results for the single patient who received a combination of DP TIL and PH-762. Clinical results for the single patient who received a combination of DP TIL and PH-762 showed tumor size reductions of
Patent Portfolio Enhancement
Phio's portfolio includes 77 issued patents, 69 of which cover its INTASYL technology. There are 19 patent families broadly covering both the composition and methods of use of the Company's self-delivering INTASYL technology and uses of INTASYL compounds targeting immune checkpoints for cancer therapy, cellular differentiation and metabolism targets for Adoptive Cell Therapy immunotherapies.
Scientific News
During 2024, Phio presented new data on its INTASYL self-delivering siRNA technology applications at several conferences including American Academy of Cancer Research (AACR), Society for Immunotherapy of Cancer (SITC), American Society of Gene and Cell Therapy (ASGCT) and at the Annual Oligonucleotide Therapeutics Society (OTS). Most recently, the Company was invited to present its phase 1b clinical trial results to date at the American Academy of Dermatology (AAD) in the Late-Breaking Research Session. The Company's INTASYL PH-804 compound was highlighted in the peer reviewed journal, Cancer Immunology, Immunotherapy in an article entitled, "INTASYL Self Delivering RNAi Decreases TIGIT Expression, Enhancing NK Cell Cytotoxicity: A Potential Application to Increase the Efficacy of NK Adoptive Cell Therapy Against Cancer", authored by M. Maxwell et al.
Financial Results
Cash Position
At December 31, 2024, the Company had cash of approximately
During the year ended December 31, 2024, the Company completed multiple financings and received total net proceeds of approximately
Subsequent to year-end, the Company completed additional financings and received total net proceeds of approximately
Research and Development Expenses
Research and development expenses for the year ended December 31, 2024 decreased approximately
General and Administrative Expenses
General and administrative expenses were approximately
Net Loss
Net loss was approximately
About Phio Pharmaceuticals Corp.
Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company advancing its proprietary INTASYL siRNA gene silencing technology to eliminate cancer. INTASYL can target and silence virtually any gene with high degree of specificity across a wide range of cell types and tissues. INTASYL is designed to enhance the ability of immune cells to more effectively kill tumor cells. INTASYL has also demonstrated enhancement to adoptive cell therapy. Notably, INTASYL is a self-delivering RNAi technology focused on immuno-oncology therapeutics without the need for formulation enhancements or manipulations to reach its target.
Phio's lead clinical program, PH-762, is an INTASYL compound that silences PD-1. PH-762 is a potential non-surgical treatment for skin cancers. The on-going Phase 1b trial (NCT# 06014086) received FDA clearance for an Investigational New Drug Application to evaluate PH-762 in the treatment of cutaneous SCC, melanoma and Merkel cell carcinoma in second quarter of 2023.
For additional information, visit the Company's website, www.phiopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "intends," "believes," "anticipates," "indicates," "plans," "expects," "suggests," "may," "would," "should," "potential," "designed to," "will," "ongoing," "estimate," "forecast," "target," "predict," "could" and similar references, although not all forward-looking statements contain these words. These statements, which include statements regarding the anticipated benefits of our INTASYL™ RNAi platform, the results from our ongoing clinical trials and our ability to successfully complete our ongoing trials with the capital we currently have on hand, are based only on our current beliefs, expectations and assumptions and are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements as a result of a number of important factors, including, but not limited to, the impact to our business and operations by inflationary pressures, rising interest rates, recession fears, the development of our product candidates, results from our preclinical and clinical activities, our ability to execute on business strategies, our ability to develop our product candidates with collaboration partners, and the success of any such collaborations, the timeline and duration for advancing our product candidates into clinical development, the timing or likelihood of regulatory filings and approvals, the success of our efforts to commercialize our product candidates if approved, our ability to manufacture and supply our product candidates for clinical activities, and for commercial use if approved, the scope of protection we are able to establish and maintain for intellectual property rights covering our technology platform, our ability to obtain future financing, market and other conditions and those risks identified in our Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q under the caption "Risk Factors" and in other filings the Company periodically makes with the SEC. Readers are urged to review these risk factors and to not act in reliance on any forward-looking statements, as actual results may differ from those contemplated by our forward-looking statements. Phio does not undertake to update forward-looking statements to reflect a change in its views, events or circumstances that occur after the date of this release, except as required by law.
Contact:
Phio Pharmaceuticals Corp.
Jennifer Phillips: jphillips@phiopharma.com
Corporate Affairs
PHIO PHARMACEUTICALS CORP.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share data)
(Unaudited)
Year Ended December 31, | |||||||
2024 | 2023 | ||||||
Operating expenses: | |||||||
Research and development | $ | 3,643 | $ | 6,332 | |||
General and administrative | 3,744 | 4,366 | |||||
Loss on impairment of property and equipment | 126 | ||||||
Total operating expenses | 7,387 | 10,824 | |||||
Operating loss | (7,387 | ) | (10,824 | ) | |||
Interest income (expense), net | 231 | (8 | ) | ||||
Other income | 6 | 6 | |||||
Net loss | $ | (7,150 | ) | $ | (10,826 | ) | |
Net loss per common share: | |||||||
Basic and diluted | $ | (9.08 | ) | $ | (46.76 | ) | |
Weighted average number of common shares outstanding | |||||||
Basic and diluted | 787,466 | 231,508 |
PHIO PHARMACEUTICALS CORP.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share data)
(Unaudited)
December 31, 2024 | December 31, 2023 | ||||||
ASSETS | |||||||
Cash | $ | 5,382 | $ | 8,490 | |||
Prepaid expenses and other current assets | 354 | 832 | |||||
Total current assets | 5,736 | 9,322 | |||||
Right of use asset | - | 33 | |||||
Property and equipment, net | 2 | 6 | |||||
Other assets | - | 3 | |||||
Total assets | $ | 5,738 | $ | 9,364 | |||
LIABILITIES, PREFERRED STOCK AND STOCKHOLDERS' EQUITY | |||||||
Accounts payable | $ | 253 | $ | 657 | |||
Accrued expenses | 762 | 942 | |||||
Lease liability | - | 35 | |||||
Total current liabilities | 1,015 | 1,634 | |||||
Total preferred stock | - | - | |||||
Total stockholders' equity | 4,723 | 7,730 | |||||
Total liabilities, preferred stock and stockholders' equity | $ | 5,738 | $ | 9,364 |
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