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Predictive Oncology Reports First Quarter 2024 Financial Results and Provides Business Update

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Predictive Oncology (Nasdaq: POAI) reported financial results for Q1 2024, revealing a net loss of $4.2 million on revenue of $0.4 million. The company highlighted key advancements, including the acceptance of a study at the ASCO Annual Meeting, a collaboration with Fujifilm, and progress with FluGen's flu vaccine project. Revenue increased from $239,895 in Q1 2023 to $419,646 in Q1 2024. However, expenses also grew, leading to a higher net loss per share of $(1.04) compared to $(0.86) the previous year. Cash reserves decreased to $5.2 million from $8.7 million at the end of 2023. Gross profit margin improved to 55% from 50% year-over-year.

Positive
  • Revenue for Q1 2024 increased to $419,646, up from $239,895 in Q1 2023.
  • Gross profit margin improved from 50% in Q1 2023 to 55% in Q1 2024.
  • Study accepted for presentation at the ASCO Annual Meeting, indicating validation of their research.
  • Collaboration with Fujifilm to improve drug safety using EndoPrep™ technology.
  • Progress in FluGen collaboration, potentially leading to future contracts for vaccine projects.
  • Continued business development efforts have led to late-stage discussions on new engagements.
Negative
  • Net loss for Q1 2024 was $4.2 million, a significant increase from the previous period.
  • General and administrative expenses rose to $2,627,076, up from $2,335,984 in Q1 2023.
  • Operational expenses increased to $1,102,193 compared to $878,518 in Q1 2023.
  • Sales and marketing expenses more than doubled to $739,734 from $370,237 in Q1 2023.
  • Cash reserves dropped to $5.2 million, down from $8.7 million at the end of 2023.
  • Net loss per share increased to $(1.04) from $(0.86) in the previous year.

Insights

Predictive Oncology's financial report for Q1 2024 raises several points of interest for retail investors. The company reported a net loss of approximately $4.2 million on total revenue of $0.4 million. While the revenue showed a year-over-year increase from $239,895 to $419,646, the net loss suggests that operational costs are outpacing revenue gains. General and administrative expenses have risen to $2.63 million, partly due to higher professional fees and business taxes. Additionally, operational expenses increased due to higher employee compensation linked to R&D efforts. Investors should note the decline in cash reserves from $8.7 million at the end of 2023 to $5.2 million by the end of Q1 2024, which could indicate potential liquidity challenges moving forward. In summary, while revenue growth and a slight improvement in gross profit margin are positive signs, the widening net loss may raise concerns about the company’s financial health.

Predictive Oncology’s focus on utilizing machine learning to predict survival outcomes in ovarian cancer is a significant development in personalized medicine. The study’s acceptance for presentation at the 2024 ASCO Annual Meeting underscores its scientific relevance. These AI-driven models could potentially serve as decision support tools in daily clinical practice, helping tailor therapies to individual patients and identifying novel biomarkers for next-generation cancer treatments. However, the transition from promising research to everyday clinical use involves regulatory approvals and real-world validation, which can be lengthy and uncertain. Investors should watch for further clinical validation and potential partnerships that could accelerate the adoption of these technologies.

The collaboration with Fujifilm to enhance bacterial endotoxin testing using Predictive Oncology’s EndoPrep™ technology highlights the company’s ability to establish strategic partnerships. This aligns with the growing demand for improved drug safety in the biopharmaceutical sector. Additionally, the ongoing progress with FluGen under a DoD grant marks a significant milestone. Successfully stabilizing a live attenuated virus for an intranasal flu vaccine could open doors for future contracts, enhancing the company’s market position. However, these projects are still in early phases and commercial success hinges on meeting technical milestones and securing further partnerships. Investors should consider these collaborations as potential long-term catalysts rather than immediate revenue drivers.

Company to host investor call and webcast today, May 15th, at 8:30am EDT

PITTSBURGH, May 15, 2024 (GLOBE NEWSWIRE) -- Predictive Oncology (Nasdaq: POAI), a science driven company leveraging its proprietary artificial intelligence and machine learning capabilities, extensive biorepository of tumor samples, CLIA laboratory and GMP facility, to accelerate oncologic drug discovery and enable drug development, today reported financial and operating results for the quarter ended March 31, 2024, and provided a corporate update. The company reported a net loss of approximately $4.2 million on total revenue of approximately $0.4 million for the quarter.

Q1 2024 and Recent Highlights:

  • Announced that an abstract detailing results of the recent study that Predictive Oncology completed in collaboration with UPMC Magee-Womens Hospital in Pittsburgh, PA, has been accepted as a poster presentation at the American Society for Clinical Oncology (ASCO) Annual Meeting, which is being held May 31-June 4 in Chicago.
    • The study utilized multi-omic machine learning models to identify molecular features that better correlate to short- and long-term survival outcomes among women diagnosed with high grade serous ovarian cancer (HGSC) as compared to clinical data alone.
    • Models hold potential as decision support tools to be incorporated into daily clinical practice to tailor therapies to individual patients and may also be used to identify novel biomarkers to advance the development of next-generation cancer therapeutics.
    • Presentation is scheduled for Monday, June 3rd, 9:00am – 12:00pm CDT (10:00am-1:00pm EDT).
  • Announced a collaboration and co-marketing agreement with Fujifilm to reduce protein interference in bacterial endotoxin testing of biopharmaceutical products, thereby improving drug safety. Per the terms of the agreement, Predictive Oncology will utilize its novel EndoPrep™ sample treatment technology, together with Fujifilm’s PYROSTAR™ bacterial endotoxin detection reagent, to detect residual endotoxins more accurately in biopharmaceuticals by eliminating protein interference from the drug product in the detection assay.
  • Reported meaningful progress with its FluGen collaboration designed to bring a first-of-its-kind intranasal flu vaccine to market, as part of a $6.2 million Phase 2b grant awarded by the U.S. Department of Defense (DoD), a portion of which will be received indirectly by Predictive Oncology, as subcontractor for FluGen, over multiple years. Per the terms of the collaboration, Predictive Oncology will play a key role in making FluGen’s M2SR flu vaccine more stable and sustainable in a refrigerated state as it advances through clinical trials.
    • Successful accomplishment of the solubility and stability goals in this collaboration – which would commercially validate the Company’s ability to solubilize and stabilize a whole live attenuated virus – may lead to future contracts with FluGen for other vaccine projects, as well as potentially other pharmaceutical companies.

“Our first quarter 2024 and subsequent results reflect the breadth and versatility of our technology, from the development of AI-driven machine learning models that can accelerate and de-risk early drug discovery, to our suite of biologics formulations and manufacturing capabilities that support leading biopharmaceutical drug developers and improve their chances of clinical success,” said Raymond F. Vennare, Chief Executive Officer and Chairman of Predictive Oncology. “Our recent announcements of projects with Fujifilm and FluGen, in particular, suggest that demand for our biologics solutions is strong while we continue to advance discussions with UPMC Magee-Womens Hospital and others on next steps following recent successful PEDAL engagements.”

“Just a few weeks ago, we announced that an abstract detailing results from a retrospective study that we completed with UPMC Magee has been accepted for presentation at the prestigious ASCO 2024 Annual Meeting. This study, in which we successfully developed active machine learning models capable of accurately predicting survival outcomes among ovarian cancer patients, has broad implications. In addition to the potential use of these models as decision support tools to be used in daily clinical practice to tailor therapies to individual patients, we see an opportunity to identify novel biomarkers which may allow us, or a licensing partner, to develop new cancer therapies on our own.”

“Since we implemented our new strategic vision for the company at the beginning of 2023, we have continued to refine our business development efforts, and we are making steady progress conveying to current and prospective partners the unique blend of assets and capabilities that we possess. Our message is resonating, as we are in late-stage discussions on a number of engagements, across both of our businesses, that we believe will continue to elevate awareness of our company among leading cancer drug developers worldwide. I look forward to accelerating contracting momentum as we progress through 2024,” concluded Mr. Vennare.

Q1 2024 Financial Summary:

  • Concluded the first quarter of 2024 with $5.2 million of cash, compared to $8.7 million as of December 31, 2023, and $4.1 million in stockholders’ equity, compared to $8.3 million as of December 31, 2023.
  • Basic and diluted net loss per common share for the quarter ended March 31, 2024, was $(1.04), compared to $(0.86) for the quarter ended March 31, 2023.

Q1 2024 Financial Results:

  • The company recorded revenue of $419,646 for the first quarter of 2024, compared to $239,895 for the comparable period in 2023. Revenues for the quarter ended March 31, 2024, and March 31, 2023, were primarily derived from the Company’s Eagan operating segment.
  • Cost of sales was $187,415 and $120,139 for the three months ended March 31, 2024, and 2023, respectively. Gross profit margin was approximately 55% and 50% for the three months ended March 31, 2024, and 2023, respectively. The improvement in gross profit margin was primarily due to a change in sales mix, with increased sales of STREAMWAY systems in the three months ended March 31, 2024.
  • General and administrative expenses increased to $2,627,076 in the first quarter of 2024 from $2,335,984 in the first quarter of 2023. The increase was primarily due to increased professional fees including audit and consultant fees as well as increased business taxes, offset by decreased employee compensation as well as decreased depreciation due to fully depreciated assets.
  • Operations expenses increased to $1,102,193 in the first quarter of 2024 compared to $878,518 in the first quarter of 2023. The increase was primarily due to increased employee compensation associated with our research and development efforts.
  • Sales and marketing expenses increased to $739,734 in the first quarter of 2024 from $370,237 in the first quarter of 2023. The increase was primarily due to severance related to a former executive.
  • Net cash used in operating activities was $3,416,021 in the first quarter of 2024 compared to net cash used of $3,427,761 in the first quarter of 2023. The increase in the Company’s net loss was primarily offset by an increase in cash provided by changes in working capital, resulting from higher accounts payable and accrued expenses.

Conference Call and Webcast Details:

Predictive Oncology management will host an investor conference call and webcast today, May 15th, 8:30 am EDT.

To participate in the call, investors and analysts should dial 1-877-407-3982 (domestic) or 1-201-493-6780 (international) and reference conference ID 13746389.

To access the Call Me™ feature, which eliminates the need to wait for a call operator, please click here.

The live webcast of the call can be accessed here.

Forward-Looking Statements:

Certain matters discussed in this release contain forward-looking statements. These forward-looking statements reflect our current expectations and projections about future events and are subject to substantial risks, uncertainties and assumptions about our operations and the investments we make. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue and financial performance, projected costs, prospects, plans and objectives of management are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “would,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our actual future performance may materially differ from that contemplated by the forward-looking statements as a result of a variety of factors including, among other things, the risks related to the success of our collaboration arrangements, commercialization activities and product sales levels by our collaboration partners, and other factors discussed under the heading “Risk Factors” in our filings with the SEC. Except as expressly required by law, the Company disclaims any intent or obligation to update these forward-looking statements.

Investor Relations Contact:
Tim McCarthy, CFA
LifeSci Advisors, LLC
tim@lifesciadvisors.com


PREDICTIVE ONCOLOGY INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
 
  March 31,
2024
 December 31,
2023
ASSETS        
Current assets:        
Cash $5,197,235  $8,728,660 
Accounts receivable  509,445   333,697 
Inventories  441,718   494,374 
Prepaid expense and other assets  412,925   521,700 
Total current assets  6,561,323   10,078,431 
         
Property and equipment, net  1,087,718   1,233,910 
Intangibles, net  245,594   252,457 
Lease right-of-use assets  2,582,456   2,728,355 
Other long-term assets  124,096   124,096 
Total assets $10,601,187  $14,417,249 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Current liabilities:        
Accounts payable $1,729,126  $1,342,027 
Note payable  38,036   150,408 
Accrued expenses and other liabilities  1,904,612   1,631,702 
Derivative liability  367   1,376 
Contract liabilities  304,320   308,091 
Lease liability  540,200   517,427 
Total current liabilities  4,516,661   3,951,031 
         
Other long-term liabilities  3,507   5,459 
Lease liability – net of current portion  2,027,348   2,188,979 
Total liabilities  6,547,516   6,145,469 
Commitments and contingencies        
         
Stockholders’ equity:        
Preferred stock, 20,000,000 shares authorized inclusive of designated below        
Series B Convertible Preferred Stock, $.01 par value, 2,300,000 shares authorized, 79,246 shares outstanding as of March 31, 2024, and December 31, 2023  792   792 
Common stock, $.01 par value, 200,000,000 shares authorized, 4,062,853 shares outstanding as of March 31, 2024, and December 31, 2023  40,629   40,629 
Additional paid-in capital  175,992,976   175,992,242 
Accumulated deficit  (171,980,726)  (167,761,883)
Total stockholders’ equity  4,053,671   8,271,780 
         
Total liabilities and stockholders’ equity $10,601,187  $14,417,249 


PREDICTIVE ONCOLOGY INC.
CONDENSED CONSOLIDATED STATEMENTS OF NET LOSS
(Unaudited)
 
  Three Months Ended
March 31, 
   2024   2023 
Revenue $419,646  $239,895 
Cost of sales  187,415   120,139 
Gross profit  232,231   119,756 
         
Operating expenses:        
General and administrative expense  2,627,076   2,335,984 
Operations expense  1,102,193   878,518 
Sales and marketing expense  739,734   370,237 
Total operating expenses  4,469,003   3,584,739 
Total operating (loss)  (4,236,772)  (3,464,983)
Other income  18,657   42,228 
Other expense  (1,737)  - 
Gain on derivative instruments  1,009   953 
Net (loss) $(4,218,843) $(3,421,802)
         
Net (loss) per common share – basic and diluted $(1.04) $(0.86)
         
Weighted average shares used in computation – basic and diluted  4,062,853   3,968,099 

 


FAQ

What were Predictive Oncology's financial results for Q1 2024?

Predictive Oncology reported a net loss of $4.2 million on revenue of $0.4 million for Q1 2024.

Did Predictive Oncology's revenue increase in Q1 2024?

Yes, revenue increased to $419,646 in Q1 2024 from $239,895 in Q1 2023.

What caused the increase in Predictive Oncology's expenses in Q1 2024?

The increase in expenses was due to higher professional fees, increased employee compensation, and severance related to a former executive.

What is the significance of the ASCO Annual Meeting for Predictive Oncology?

The ASCO Annual Meeting is significant as Predictive Oncology's study on ovarian cancer survival outcomes was accepted for presentation, showcasing their research capabilities.

How did Predictive Oncology's gross profit margin change in Q1 2024?

The gross profit margin improved to 55% in Q1 2024 from 50% in Q1 2023.

What are the details of Predictive Oncology's collaboration with Fujifilm?

Predictive Oncology and Fujifilm are collaborating to reduce protein interference in bacterial endotoxin testing, enhancing drug safety with EndoPrep™ technology.

How is Predictive Oncology involved in the FluGen collaboration?

Predictive Oncology is helping to stabilize FluGen's intranasal flu vaccine, which could lead to future contracts for other vaccine projects.

What was Predictive Oncology's net loss per share in Q1 2024?

The net loss per share for Q1 2024 was $(1.04), compared to $(0.86) in Q1 2023.

What were Predictive Oncology's cash reserves at the end of Q1 2024?

Predictive Oncology's cash reserves were $5.2 million at the end of Q1 2024, down from $8.7 million at the end of 2023.

What is the status of Predictive Oncology's business development efforts?

Predictive Oncology is in late-stage discussions on several new engagements, indicating progress in business development efforts.

Predictive Oncology Inc.

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