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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): August 11, 2022
_______________________________
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.) |
2915 Commers Drive, Suite 900
Eagan, Minnesota 55121
(Address of Principal Executive Offices) (Zip Code)
(651) 389-4800
(Registrant's telephone number, including area code)
Not Applicable
(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 August 11, 2022, Predictive Oncology Inc. issued a press release attached hereto as Exhibit 99.1 announcing its financial results for the three months ended June 30, 2022.
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 August 11, 2022 |
| 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: August 11, 2022 | By: | /s/ Bob Myers |
| Bob Myers | ||
| Chief Financial Officer |
EdgarFiling EXHIBIT 99.1
Predictive Oncology Reports Second Quarter 2022 Financial Results
EAGAN, Minn., Aug. 11, 2022 (GLOBE NEWSWIRE) -- Predictive Oncology Inc. (NASDAQ: POAI) today announced the financial results for its second quarter ended June 30, 2022, which shows a strong balance sheet with a solid cash balance, commensurate equity and no debt. Highlights from the quarter include:
- Commercialization launch of PeDAL, our innovative AI product, and presence at BIO International that included one-on-one partnering meetings with pharmaceutical and biotech companies
- The appointment of Julia Kirshner, Ph.D., as Chief Scientific Officer
- The consolidation and expansion of the research and development arm in Pittsburgh with the move of TumorGenesis to that location
- An increase of cash and equivalents from $25 million on March 31, 2022, to $28 million at quarter end, which represents a positive change of 12%
Q2 2022 financial results Predictive Oncology’s recognized net sales revenue of $0.4 million for the quarter was an increase of 6% from the comparative three-month period in 2021. The positive change was mainly due to zPREDICTA recognizing sales of $0.1 million.
The gross profit margin grew from 59% in the second quarter of 2021 to 64% for the comparable quarter of 2022. The increase is directly attributable to zPREDICTA with strong margins.
Net cash used in operating activities was $6.4 million and $5.5 million for the six months ended June 30, 2022, and June 30, 2021, respectively, primarily because of the increase in operating costs associated with zPREDICTA and POAI’s PeDAL commercial strategy.
General and administrative expenses increased from $2.1 million in the quarter ended June 30, 2021, to $2.4 million for the corresponding quarter in 2022. Operations expenses increased from $0.6 million in the quarter ended June 30, 2021 to $0.9 million in the quarter ended June 30, 2022, primarily due to higher staffing at zPREDICTA. This was partially offset by the timing of research and development expenses and lower consulting expenses.
Quarterly sales and marketing expenses of the company increased by $0.1 million for the quarter ended June 30, 2022, to $0.3 million, as compared to the corresponding period in 2021, due to staff-related expenses and the implementation of advertising and marketing initiatives.
Current market conditions, coupled with POAI’s lower quantitative valuation of zPREDICTA, resulted in a $7.2 million (non-cash) goodwill impairment in the quarter. zPREDICTA is anticipating stronger business growth in the second half of the year with current and potential customers of its validated models for multiple myeloma (existing), breast cancer (new) and pancreatic cancer (new), as well as the development of new therapies in immuno-oncology.
Other developments First is the strategic move POAI made to further strengthen the company’s scientific and product offerings with the appointment of Dr. Julia Kirshner as Chief Scientific Officer. Dr. Kirshner was elevated from her role as Senior Vice President of Predictive Oncology and President of zPREDICTA (the company she founded and POAI acquired in Q4 2021). Dr. Kirshner will focus on the integration of POAI’s product lines and future development of its scientific programs. She will also be working closely with Dr. Pamela Bush, Senior Vice President of Strategic Sales and Business Development, to identify and meet customer needs and provide expanded solutions along the AI and drug development continuum.
Second is POAI’s decision to streamline the company’s research and development operations, which Dr. Kirshner will oversee. POAI will consolidate its TumorGenesis division by moving this business from Massachusetts to the flagship location in Pittsburgh, PA. By doing this, POAI can better focus on growth opportunities with its artificial intelligence technology and lab functions, while reducing overhead and centralizing scientific operations. This also provides the potential to bring in greater revenue levels as the company explores more expanded offerings for clients in the pharmaceutical and biotech industries.
Additionally, POAI attended the BIO International conference in June, specifically presenting PeDAL and Soluble Biotech. POAI launched the PeDAL platform as part of a comprehensive business development and marketing plan aimed to establish key relationships with targeted pharmaceutical and biotech companies. Soluble Biotech also looked to expand its customer base at the conference with parallel initiatives.
Shareholder earnings call POAI will conduct a 2Q 2022 shareholder earnings call to take place on Friday, August 12, at 12:00 PM ET. The links to register for the webcast will be available at the links below: To register and view the webcast, please go to this link: https://edge.media-server.com/mmc/p/it32fi7n. For Q&A’s, please register here: https://register.vevent.com/register/BI2e83830dc64a4a8c8a33753ecde1ac52
About Predictive Oncology Inc. Predictive Oncology (NASDAQ: POAI) is a knowledge-driven company, applying artificial intelligence to develop personalized cancer therapies that improve patient outcomes. The company, which offers a suite of solutions for oncology drug development, operates through four segments (Skyline, Helomics, zPREDICTA and Soluble), which covers five subsidiaries: Helomics, zPREDICTA, Soluble Biotech, TumorGenesis and Skyline Medical.
Helomics Holding Corporation is involved in applying artificial intelligence (“AI”) in the Company’s precision medicine business, to offer AI-driven predictive models of tumor drug response to enhance clinical results for patients and to aid diagnostic, biotech and pharmaceutical companies in new personalized diagnostic and drug development. Skyline Medical Inc. (“Skyline Medical”) sells the STREAMWAY System®, a fully automated wall-mounted product, which is utilized to dispose of an unlimited quantity of suction fluid in an operating room setting. It offers continuous performance for medical practitioners by effectively eradicating the healthcare professional’s exposure to potentially infectious liquids gathered during surgical and other medical operations. Soluble Biotech Inc. is involved in research and commercialization focused on protein production, stability studies and solubility improvements. zPREDICTA, Inc. does tumor-specific research using in vitro models for oncology and drug development. TumorGenesis serves as the company’s arm for research and development for zPREDICTA, Soluble and Helomics. This subsidiary is also involved in cellular media kit production which aids cancer cells to grow outside the body of patients while preserving their proteomic and RNA/DNA signatures.
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, changes in management, 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, 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.
PREDICTIVE ONCOLOGY INC. CONDENSED CONSOLIDATED BALANCE SHEETS
| December 31, 2021 | |||||
|---|---|---|---|---|---|
| (audited) | |||||
| ASSETS | |||||
| Current Assets: | |||||
| Cash and Cash Equivalents | 28,249,452 | $ | 28,202,615 | ||
| Accounts Receivable | 336,397 | 354,196 | |||
| Inventories | 474,616 | 387,684 | |||
| Prepaid Expense and Other Assets | 763,053 | 513,778 | |||
| Total Current Assets | 29,823,518 | 29,458,273 | |||
| Fixed Assets, net | 2,300,327 | 2,511,571 | |||
| Intangibles, net | 3,790,637 | 3,962,118 | |||
| Lease Right-of-Use Assets | 505,667 | 814,454 | |||
| Other Long-Term Assets | 75,618 | 167,065 | |||
| Goodwill | - | 6,857,790 | |||
| Total Assets | 36,495,767 | 43,771,271 | |||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||
| Current Liabilities: | |||||
| Accounts Payable | 983,672 | $ | 1,021,774 | ||
| Accrued Expenses and other liabilities | 856,654 | 1,262,641 | |||
| Derivative Liability | 32,318 | 129,480 | |||
| Deferred Revenue | 530,797 | 186,951 | |||
| Lease Liability | 421,736 | 639,662 | |||
| Total Current Liabilities | 2,825,177 | 3,240,508 | |||
| Lease Liability – Net of current portion | 113,462 | 239,664 | |||
| Other long-term liabilities | 21,731 | 25,415 | |||
| Total Liabilities | 2,960,370 | 3,505,587 | |||
| Stockholders’ Equity: | |||||
| Preferred Stock, 20,000,000 authorized inclusive of designated below | |||||
| Series B Convertible Preferred Stock, .01 par value, 2,300,000 shares authorized, 79,246 shares outstanding | 792 | 792 | |||
| Common Stock, .01 par value, 200,000,000 shares authorized, 78,155,127 and 65,614,597 outstanding | 781,551 | 656,146 | |||
| Additional paid-in capital | 174,555,375 | 167,649,028 | |||
| Accumulated Deficit | (141,802,321 | ) | (128,040,282 | ) | |
| Total Stockholders’ Equity | 33,535,397 | 40,265,684 | |||
| Total Liabilities and Stockholders’ Equity | 36,495,767 | $ | 43,771,271 |
All values are in US Dollars.
PREDICTIVE ONCOLOGY INC. CONDENSED CONSOLIDATED STATEMENTS OF NET LOSS (Unaudited)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | 2022 | 2021 | |||||||||
| Revenue | $ | 371,591 | $ | 350,207 | $ | 686,159 | $ | 630,524 | ||||
| Cost of goods sold | 134,075 | 142,877 | 243,518 | 240,635 | ||||||||
| Gross profit | 237,516 | 207,330 | 442,641 | 389,889 | ||||||||
| General and administrative expense | 2,351,696 | 2,077,973 | 4,775,347 | 5,348,750 | ||||||||
| Operations expense | 909,113 | 567,796 | 1,800,184 | 1,142,608 | ||||||||
| Sales and marketing expense | 271,022 | 159,788 | 575,489 | 274,429 | ||||||||
| Loss on impairment of goodwill | 7,231,093 | - | 7,231,093 | - | ||||||||
| Total operating loss | (10,525,408 | ) | (2,598,227 | ) | (13,939,472 | ) | (6,375,898 | ) | ||||
| Other income | 41,047 | 57,033 | 83,477 | 85,292 | ||||||||
| Other expense | (2,217 | ) | (1,829 | ) | (3,206 | ) | (236,801 | ) | ||||
| Gain (loss) on derivative instruments | 95,254 | (30,909 | ) | 97,162 | 64,762 | |||||||
| Net loss | $ | (10,391,324 | ) | $ | (2,573,932 | ) | $ | (13,762,039 | ) | $ | (6,462,645 | ) |
| Net loss attributable to common shareholders per common shares-basic and diluted | $ | (10,391,324 | ) | $ | (2,573,932 | ) | $ | (13,762,039 | ) | $ | (6,462,645 | ) |
| Loss per common share basic | $ | (0.15 | ) | $ | (0.05 | ) | $ | (0.20 | ) | $ | (0.15 | ) |
| Loss per common share diluted | $ | (0.15 | ) | $ | (0.05 | ) | $ | (0.20 | ) | $ | (0.15 | ) |
| Weighted average shared used in computation - basic | 68,896,506 | 51,581,762 | 67,374,250 | 44,089,157 | ||||||||
| Weighted average shared used in computation - diluted | 68,896,506 | 51,581,762 | 67,374,250 | 44,089,157 |
Media relations contact: Predictive Oncology Theresa Ferguson 630-566-2003 tferguson@predictive-oncology.com
Investor relations contact: Landon Capital Keith Pinder (404) 995-6671 kpinder@landoncapital.net