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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): December 1, 2023
BIOAFFINITY TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-41463 | 46-5211056 | ||
|
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification Number) |
22211 W Interstate 10
Suite 1206
San Antonio, Texas 78257
(210) 698-5334
(Address of principal executive offices and Registrant’s telephone number, including area code)
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 (see General Instruction A.2. below):
| ☐ | 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)) |
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 ☒
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| Common Stock, par value $.007 per share | BIAF | The Nasdaq Stock Market LLC | ||
| Tradeable Warrants to purchase Common Stock | BIAFW | The Nasdaq Stock Market LLC |
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 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
New Director Appointment
On December 1, 2023, the Board of Directors (the “Board”) of bioAffinity Technologies, Inc. (the “Company”) appointed Jamie Platt, Ph.D., to serve as a director of the Company. Ms. Platt was also appointed to serve as a member of the Compensation Committee of the Board.
Dr. Platt, age 57, brings 20 years of progressive leadership in genomics and molecular diagnostics, guiding teams in developing, validating, and commercializing more than 40 innovative, high-complexity molecular tests for U.S. and global firms, both laboratory developed tests (“LDTs”) and in vitro diagnostic tests (“IVDs”). Since April 2023, she has served as Managing Director and Chief Executive Officer at Pictor Ltd., an in-vitro diagnostics company using a proprietary enzyme-linked immunosorbent assay (“ELISA”) platform to test complex and infectious diseases, and since January 2021, has served as a member of its board of directors. From August 2021 until April 2023, Dr. Platt served as Chief Operations Officer at Personal Genome Diagnostics, a company dedicated to advancing precision oncology acquired by Laboratory Corporation of America Holdings. Since May 2015, Dr. Platt has served as President and Chief Executive Officer of BRIDGenomics, a private consulting and contract commercialization firm she founded in 2015 to provide molecular and genomic-based strategies to clients. Dr. Platt has served since March 2021 as a member of the board of directors of DxTerity Diagnostics Inc. , a company pioneering the use of RNA-based immune system profiling to better understand the root causes of immune mediated conditions. From February 2017 until January 2021, Dr. Platt served as Chief Operations Officer of Inivata Limited, a company applying pioneering liquid biopsy technology acquired by NeoGenomics Laboratories, Inc.
Dr. Platt earned her Ph.D. in molecular and cellular biology from Oregon State University and completed post-doctoral studies at the University of California, Berkeley. Dr. Platt is an industry-recognized peer educator and speaker, holds multiple U.S. and international patents and has authored numerous peer-reviewed publications.
Dr. Platt will receive the standard compensation available to the Company’s current non-employee directors, which is an annual fee of $25,000 for serving on the Board and for committee service, and a quarterly grant of restricted stock under the Company’s 2014 Equity Incentive Plan, as amended, having a value of $18,750 on the date of grant, vesting on the three-month anniversary of the grant date, subject to her continued service as a director through such date.
There are no family relationships between Dr. Platt and any of the Company’s directors or executive officers, nor does Dr. Platt have any direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K. Other than as described above, there were no arrangements or understandings by which Dr. Platt was appointed as a member of the Board.
Director Resignation
On December 1, 2023, Mohsin Y. Meghji resigned from the Board of Directors, effective immediately, for personal reasons, and not due to any disagreement with the Company or its operations, policies or practices.
Item 7.01. Regulation FD Disclosure.
On December 5, 2023, the Company issued a press release announcing the appointment of Jamie Platt, Ph.D., to the Board. A copy of the press release is furnished with this Current Report on Form 8-K as Exhibit 99.1 and is incorporated in this Item 7.01 by reference.
The information in this Item 7.01 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 7.01 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
The press release attached as Exhibit 99.1 to this Current Report on Form 8-K includes “safe harbor” language pursuant to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained therein are “forward-looking” rather than historical.
The Company undertakes no duty or obligation to update or revise the information contained in this Current Report on Form 8-K, although it may do so from time to time if its management believes it is appropriate. Any such updating may be made through the filing of other reports or documents with the Securities and Exchange Commission, through press releases or through other public disclosures.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | ||
| 10.1 | Jamie Platt Offer Letter | ||
| 99.1 | Press Release of bioAffinity Technologies, Inc. dated December 5, 2023 | ||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
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.
| BIOAFFINITY TECHNOLOGIES, INC. | ||
| By: | /s/ Maria Zannes | |
| Maria Zannes | ||
| President and Chief Executive Officer | ||
Dated: December 5, 2023
Exhibit 10.1
December 1, 2023
Dr. Jamie Platt
dr.jamie.platt@gmail.com
Dear Dr. Platt:
As you know, bioAffinity Technologies is developing breakthrough technology for the early diagnosis of lung cancer and other diseases of the lung, as well as researching novel approaches for the treatment of cancer. Our Board of Directors plays a central role in our important work. I was pleased to learn of your interest in a position as a Member of the Board of Directors, and I am equally pleased to report that the Board of Directors elected you on December 1, 2023, to service as a Board Member. Your experience and involvement in the biomedical field make you uniquely qualified for the position. I hope you will accept the position by signing this letter and returning a copy to me.
Board Members receive an annual compensation of $100,000 of which $75,000 is paid in equity and $25,000 in cash. At this time, compensation is paid on a quarterly basis.
The primary responsibility of Directors is participation in the development of policy and major decision-making at Board Meetings held at least four times a year. We are preparing our 2024 schedule of Board Meetings and I will work with you to identify possible dates and times that meet your schedule. You will receive materials before each Board Meeting consisting of an Agenda, a Report to the Board summarizing our progress of the prior quarter and upcoming initiatives, quarterly financials, resolutions submitted for approval and supporting information that would be helpful in carrying out your duties. The Board elected you to sit on the Compensation Committee that meets at least twice each year.
I very much look forward to working closely with you in the years ahead. Your leadership and guidance will be key to our success.
Please sign below in acceptance of the position.
| Sincerely, | Accepted this 1st day of December, 2023 |
| /s/ Maria Zannes | /s/ Jamie Platt | |
| Maria Zannes | Jamie Platt, PhD | |
| Director, President & CEO |
Exhibit 99.1
bioAffinity Technologies Appoints Jamie Platt, Ph.D., to its Board of Directors
SAN ANTONIO, Texas (Dec. 5, 2023) – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer and lung disease, today announced the appointment of Jamie Platt, Ph.D., to its Board of Directors effective Dec. 1, 2023. Dr. Platt has two decades of experience bringing novel diagnostic technologies to global markets.
“Dr. Platt’s impressive track record in transforming research organizations into successful commercial entities, her commitment to operational excellence and innovation, and her extensive experience in expanding product market share in the diagnostics market make her a valuable asset to our team as we move forward with the commercialization of CyPath® Lung, our noninvasive test for the early detection of lung cancer,” bioAffinity Technologies President and CEO Maria Zannes said. “We are pleased to welcome Dr. Platt to our Board where we believe her scientific acumen, business leadership and board experience will be influential in driving bioAffinity’s growth and success.”
Dr. Platt was instrumental in two M&A exits for diagnostic companies that were completed in 2022, resulting in a combined value of nearly $1 billion. Dr. Platt was Chief Operating Officer (COO) of Personal Genome Diagnostics which was acquired by LabCorp for $575 million. She also served as COO at Inivata, Inc. where she led operations in support of a next-generation sequencing (NGS) liquid biopsy laboratory developed test, which was acquired by Neogenomics. Dr. Platt began her career at Quest Diagnostics where she assumed progressively greater leadership responsibilities before transitioning to Vice President of Genomic Solutions at Molecular Pathology Laboratory Network, which provides comprehensive services and innovative technologies in laboratory medicine to clients in pathology groups, hospitals, medical laboratories and physician groups nationwide.
Dr. Platt currently serves as the Managing Director and CEO of Pictor Limited where she is leading a turnaround by restructuring and accelerating product development. Under her leadership, the company raised a Series A funding and enhanced the board with expertise from U.S. and international markets. Concurrently, she is President and CEO of BRIDGenomics, LLC, a private consulting and contract commercialization firm she founded in 2015 to provide molecular and genomic-based strategies to clients.
In addition to her role on the board of Pictor Limited, Dr. Platt has served on the boards of Mobility Health, a biohealth diagnostic company focused on precise, rapid infectious disease testing, and DxTerity, a leader in genomic immune-mediated diagnostic technology that develops easy-to-use, fast and affordable genomic tests for disease diagnosis and monitoring. In addition to her board seats, Dr. Platt has held scientific advisory roles for Roche and Genomics England and served on several working groups in the diagnostics, regulatory and genomic areas.
“I am deeply honored to join the bioAffinity Technologies Board of Directors,” Dr. Platt said. “As a molecular and cellular biologist, I appreciate the science behind the CyPath ® Lung technology and recognize its potential to transform patients’ lives by detecting lung cancer and other lung diseases early when outcomes are better. I look forward to contributing to the growth and success of bioAffinity Technologies as this talented team continues to innovate and redefine what’s possible in early-stage cancer detection and treatment.”
Dr. Platt replaces Mohsin Y. Meghji who stepped down from the Board of Directors on Dec. 1, 2023, after serving four years. Mr. Meghji’s resignation was for personal reasons and not due to any disagreement with the Company or its operations, policies or practices. “We want to thank Mr. Meghji for his valuable contributions to bioAffinity. It has been a pleasure to work with him, and we wish him well on his future endeavors,” Ms. Zannes said.
About CyPath® Lung
CyPath® Lung uses flow cytometry to identify cell populations in patient sputum that indicate malignancy. Automated data analysis developed using proprietary artificial intelligence can help determine if cancer is present or if the patient is cancer-free. CyPath® Lung incorporates a fluorescent porphyrin, TCPP, that is preferentially taken up by cancer and cancer-related cells. In a clinical trial, CyPath® Lung showed 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Half of all patients in the trial who had cancer were diagnosed in early Stages I or II. Diagnosing and treating early-stage cancer can increase patient survival and improve outcomes.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and diseases of the lung and targeted cancer treatment. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity and specificity for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies, Inc. Research and optimization of the Company’s platform technologies are conducted in its laboratories at Precision Pathology and The University of Texas at San Antonio. For more information, visit www.bioaffinitytech.com and follow us on LinkedIn and X (Twitter).
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and assumptions and include statements regarding Ms. Platt’s expected contributions, such as her scientific acumen, business leadership and board experience being instrumental in driving bioAffinity’s growth and success and the potential of the CyPath® Lung technology to transform patients’ lives by detecting lung cancer and other diseases of the lung early. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability to derive benefits from Dr. Platt’s contributions, the ability of the CyPath® Lung technology to transform patients’ lives and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
Contact
bioAffinity Technologies
Julie Anne Overton
Director of Communications
jao@bioaffinitytech.com
Investor Relations
Dave Gentry
RedChip Companies Inc.
1-800-RED-CHIP (733-2447)
Or 407-491-4498
BIAF@redchip.com