0001171843-23-007073.txt : 20231114 0001171843-23-007073.hdr.sgml : 20231114 20231114070124 ACCESSION NUMBER: 0001171843-23-007073 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20231114 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20231114 DATE AS OF CHANGE: 20231114 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Predictive Oncology Inc. CENTRAL INDEX KEY: 0001446159 STANDARD INDUSTRIAL CLASSIFICATION: ORTHOPEDIC, PROSTHETIC & SURGICAL APPLIANCES & SUPPLIES [3842] IRS NUMBER: 331007393 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36790 FILM NUMBER: 231401527 BUSINESS ADDRESS: STREET 1: 91 43RD STREET STREET 2: SUITE 110 CITY: PITTSBURGH STATE: PA ZIP: 15201 BUSINESS PHONE: 412-432-1500 MAIL ADDRESS: STREET 1: 91 43RD STREET STREET 2: SUITE 110 CITY: PITTSBURGH STATE: PA ZIP: 15201 FORMER COMPANY: FORMER CONFORMED NAME: Precision Therapeutics Inc. DATE OF NAME CHANGE: 20180314 FORMER COMPANY: FORMER CONFORMED NAME: Precision Therapeutic Inc. DATE OF NAME CHANGE: 20180208 FORMER COMPANY: FORMER CONFORMED NAME: Skyline Medical Inc. DATE OF NAME CHANGE: 20130807 8-K 1 f8k_111323.htm FORM 8-K Form 8-K
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

_________________

FORM 8-K

_________________

CURRENT REPORT

Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  November 14, 2023

_______________________________

Predictive Oncology Inc.

(Exact name of registrant as specified in its charter)

_______________________________

Delaware 001-36790 33-1007393
(State or Other Jurisdiction of Incorporation) (Commission File Number) (I.R.S. Employer Identification No.)

91 43rd Street, Suite 110

Pittsburgh, Pennsylvania 15201

(Address of Principal Executive Offices) (Zip Code)

(412) 432-1500

(Registrant's telephone number, including area code)

 

(Former name or former address, if changed since last report)

_______________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol(s) Name of each exchange on which registered
Common stock, $0.01 par value POAI Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 
 
Item 2.02. Results of Operations and Financial Condition.

On November 14, 2023, Predictive Oncology Inc. issued a press release attached hereto as Exhibit 99.1 announcing its financial results for the three months ended September 30, 2023.

Item 9.01. Financial Statements and Exhibits.

(a) Not applicable.

(b) Not applicable.

(c) Not applicable.

(d) Exhibits

Exhibit No.   Description
        
99.1   Press Release dated November 14, 2023
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)
 
 

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

  Predictive Oncology Inc.
     
   
Date: November 14, 2023 By:  /s/ Josh Blacher        
    Josh Blacher
    Interim Chief Financial Officer
   

 

EX-99.1 2 exh_991.htm PRESS RELEASE EdgarFiling

EXHIBIT 99.1

Predictive Oncology Reports Third Quarter 2023 Financial Results and Provides Business Update

Company to host investor call and webcast today, November 14th, at 8:30am EDT

PITTSBURGH, Nov. 14, 2023 (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 three and nine months ended September 30, 2023, and provided a corporate update. The company reported a net loss of $3.2 million on total net revenue of $0.7 million for the third quarter 2023.

Q3 2023 and Recent Highlights:

  • Successfully delivered actionable results of first campaign with Cancer Research Horizons (CRH) in which Predictive Oncology predicted, with a high degree of accuracy, which cancer types and patient populations are most likely to respond to CRH’s pre-clinical glutaminase inhibitors, informing future clinical development pathways.
  • Announced successful completion of a molecular characterization study in collaboration with UPMC Magee-Womens Hospital. The study identified the key molecular features that drive overall survival in ovarian cancer by employing multi-omic machine learning models that may support tailoring of therapies to individual patients to positively affect overall survival.
  • Reported a 22% reduction in net loss in the third quarter of 2023 versus the third quarter of 2022, driven by lower General and Administrative expenses.

“We recently achieved a key milestone with the delivery of successful results from our first campaign with Cancer Research Horizons, a subsidiary of the largest independent funder of cancer research in the world,” said Raymond F. Vennare, Chief Executive Officer and Chairman of Predictive Oncology. “In this ground-breaking and validating work, we leveraged our PEDAL platform and capabilities to evaluate their pre-clinical glutaminase inhibitors to predict, with a high degree of accuracy, which cancer types and patient populations are most likely to respond to these compounds, providing actionable information that can inform future clinical development pathways. The results from this initial PEDAL campaign further create value by validating the data package for these assets, making them ideal candidates for potential out-licensing.”  

“We were also very pleased to announce, just a few days ago, the completion of a molecular characterization study in collaboration with UPMC Magee-Womens Hospital in Pittsburgh to identify the key molecular features that drive overall survival in ovarian cancer. In addition to demonstrating the versatility of our technology, we believe these findings will ultimately contribute to the development of personalized therapies that extend the overall survival of ovarian cancer patients.

“I am pleased with our progress to date and believe we have created a solid foundation on which to drive future growth,” Mr. Vennare concluded.

Q3 2023 Financial Summary:

  • Concluded the third quarter of 2023 with $11.9 million in cash and cash equivalents, compared to $22.1 million as of December 31, 2022, and $11.7 million in Stockholder’s Equity, compared to $21.8 million as of December 31, 2022.
  • Loss per common share for Q3 2023 was $0.78, as compared to $1.04 for the third quarter of 2022.

Q3 2023 Financial results

  • Predictive Oncology recorded revenue of $715,056 in the third quarter of 2023, compared to $455,827 for the comparable period in 2022. The increase in revenues related primarily to higher sales of 3-D models in the current year.
  • Gross profit margin increased to 85% during the three months ended September 30, 2023 as compared to 76% in the comparable period in 2022 due to sales mix and higher margins on contracted services.
  • G&A expenses decreased by $704,344 to $2,583,574 for the three months ended September 30, 2023, compared to $3,287,918 for the same period in 2022. The decrease was primarily due to lower severance to former employees as well as decreased depreciation and amortization expenses due to fully depreciated assets and prior period impairments.
  • Operations expense decreased by $14,551 to $842,579 for the three months ended September 30, 2023 compared to $857,130 for the comparable period in 2022. The decrease was primarily due to decreased consultant fees and decreased spending on tools, calibration, and testing in the Eagan, MN facility.
  • Sales and marketing expenses were roughly flat at $336,043 for the three months ended September 30, 2023, compared to $333,377 for the same period in 2022.
  • Net cash used in operating activities was $10,107,030 and $9,135,812 for the nine months ended September 30, 2023 and September 30, 2022, respectively. Cash used in operating activities increased in the 2023 period primarily due to an increase in operating expenses and changes in working capital.

Conference call and webcast details:

Predictive Oncology management will host an investor conference call and webcast today, November 14th, at 8:30am 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 13741390.

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)

  September 30,
2023
 December 31,
2022
ASSETS        
Current assets:        
Cash and cash equivalents $11,915,048  $22,071,523 
Accounts receivable  544,756   331,196 
Inventories  439,989   430,493 
Prepaid expense and other assets  620,692   526,801 
Total current assets  13,520,485   23,360,013 
         
Property and equipment, net  1,392,681   1,833,255 
Intangibles, net  259,320   253,865 
Lease right-of-use assets  2,870,286   211,893 
Other long-term assets  124,096   75,618 
Total assets $18,166,868  $25,734,644 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Current liabilities:        
Accounts payable $1,168,226  $943,452 
Note payable  260,220   - 
Accrued expenses and other liabilities  1,810,838   2,229,075 
Derivative liability  2,109   13,833 
Contract liabilities  374,957   602,073 
Lease liability  555,541   94,237 
Total current liabilities  4,171,891   3,882,670 
         
Lease liability – net of current portion  2,343,622   86,082 
Total liabilities  6,515,513   3,968,752 
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 September 30, 2023 and December 31, 2022  792   792 
Common stock, $.01 par value, 200,000,000 shares authorized, 4,033,293 and 3,938,160 shares outstanding as of September 30, 2023 and December 31, 2022, respectively  40,333   39,382 
Additional paid-in capital  175,896,766   175,503,634 
Accumulated deficit  (164,286,536)  (153,777,916)
Total stockholders’ equity  11,651,355   21,765,892 
         
Total liabilities and stockholders’ equity $18,166,868  $25,734,644 


PREDICTIVE ONCOLOGY INC.
CONDENSED CONSOLIDATED STATEMENTS OF NET LOSS
(Unaudited)

   Three Months Ended
September 30,

   Nine Months Ended
September 30,

 
   2023   2022   2023   2022 
Revenue $715,056  $455,827  $1,445,061  $1,141,986 
Cost of goods sold  106,940   108,151   386,840   351,669 
Gross margin  608,116   347,676   1,058,221   790,317 
                 
General and administrative expense  2,583,574   3,287,918   7,624,085   8,063,265 
Operations expense  842,579   857,130   2,714,139   2,657,314 
Sales and marketing expense  336,043   333,377   1,135,383   908,867 
Loss on impairment of goodwill  -   -   -   7,231,093 
Loss on impairment of property and equipment  -   -   162,905   - 
Total operating loss  (3,154,080)  (4,130,749)  (10,578,291)  (18,070,222)
Other income  47,838   63,047   118,618   146,524 
Other expense  (60,671)  (2,001)  (60,671)  (5,207)
Gain on derivative instruments  3,463   10,219   11,724   107,381 
Net loss $(3,163,450) $(4,059,484) $(10,508,620) $(17,821,524)
                 
Net loss per common share – basic and diluted $(0.78) $(1.04) $(2.63) $(4.95)
                 
Weighted average shares used in computation – basic and diluted  4,031,356   3,919,203   3,998,887   3,602,515 

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