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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): October 8, 2026
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) |
3300
Nacogdoches Road, Suite 216
San
Antonio, Texas 78217
(Address
of principal executive offices, including zip code)
(210)
698-5334
(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 (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)) |
| Title
of each class |
|
Trading
Symbols |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.007 per share
|
|
BIAF
|
|
The
Nasdaq Stock Market LLC
(Nasdaq
Capital Market) |
| |
|
|
|
|
| Warrants to purchase Common
Stock |
|
BIAFW |
|
The
Nasdaq Stock Market LLC
(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 checkmark 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
1.01 Entry into a Material Definitive Agreement.
On
October 8, 2026, bioAffinity Technologies, Inc. (the “Company”) entered into a securities purchase agreement (the “Purchase
Agreement”) with an institutional investor, pursuant to which the Company agreed to issue and sell to such investor: (i) 116,545
shares (the “Shares”) of common stock of the Company (the “Common Stock”), and (ii) pre-funded warrants to purchase
up to an aggregate of 536,836 shares of Common Stock (the “Pre-Funded Warrants”). The offering price was $6.122 per Share
and $6.115 per Pre-Funded Warrant. The Shares and Pre-Funded Warrants were offered by the Company pursuant to its shelf registration
statement on Form S-3 (File No. 333-275608), which was declared effective by the Securities and Exchange Commission on November 27, 2023.
For
each share of Common Stock or Pre-Funded Warrant purchased by the investors, the Company, in a private placement pursuant to the Purchase
Agreement, concurrently issued to such investors an unregistered warrant (each a “Warrant” and, collectively, the “Warrants”)
to purchase one an aggregate of 980,072 shares of Common Stock. The
Warrants have an exercise price of $6.122 per share, and are exercisable commencing on the date of stockholder approval (the “Initial
Exercise Date”) and for a period of five years from the Initial Exercise Date. Such Warrants may be exercised on a cashless basis
if at the time of exercise there is no effective registration statement registering, or the prospectus contained therein is not available
for the resale of, the shares issuable upon exercise of Warrants. The exercise price is subject to customary adjustments in the event
of stock splits, stock dividends and similar recapitalization transactions.
The
Warrant contains a beneficial ownership limitation which provides that the Company shall not effect any exercise, and a holder shall
not have the right to exercise, any portion of a Warrant to the extent that, after giving effect to the exercise, such holder (together
with such holder’s affiliates) would beneficially own in excess of 4.99% of the number of shares of common stock outstanding immediately
after giving effect to the issuance of shares issuable upon the exercise. This limitation may be waived (up to a maximum of 9.99%) by
a holder in its sole discretion upon not less than sixty-one (61) days’ prior notice to the Company.
In
connection with the private placement transaction, the Company entered into a registration rights agreement (the “Registration
Rights Agreement”) with the investor, pursuant to which the Company agreed to prepare and file a registration statement (the “Resale
Registration Statement”) with the Securities and Exchange Commission (the “SEC”) registering the resale of the PIPE
Shares and the Warrant Shares no later than 45 days after the date of the Registration Rights Agreement, and to use best efforts to have
the registration statement declared effective no later than 90 days after the date of the Registration Rights Agreement (or 120 days
following the date of the Registration Rights Agreement in the event of a “full review” by the SEC).
The
closing of the sales of these securities under the Purchase Agreement took place on October 9,
2026.
The
gross proceeds from the offering were approximately $4 million, prior to deducting placement agent’s fees and other offering expenses
payable by the Company. The Company intends to use the net proceeds from the offering for working capital and other general corporate
purposes.
The
Warrants and the shares issuable upon exercise of the Warrants were sold without registration under the Securities Act of 1933 (the “Securities
Act”) in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act as transactions not involving a public offering
and Rule 506 promulgated under the Securities Act as sales to accredited investors, and in reliance on similar exemptions under applicable
state laws.
The
representations, warranties and covenants contained in the Purchase Agreement were made solely for the benefit of the parties to the
Purchase Agreement. In addition, such representations, warranties and covenants (i) are intended as a way of allocating the risk between
the parties to the Purchase Agreement and not as statements of fact, and (ii) may apply standards of materiality in a way that is different
from what may be viewed as material by stockholders of, or other investors in, the Company. Accordingly, the Purchase Agreement is included
with this filing only to provide investors with information regarding the terms of the transaction, and not to provide investors with
any other factual information regarding the Company. Moreover, information concerning the subject matter of the representations and warranties
may change after the date of the Purchase Agreement, which subsequent information may or may not be fully reflected in public disclosures.
On
October 8, 2026, the Company entered into a placement agency agreement (the “Placement Agency
Agreement”) with WallachBeth Capital LLC,
as exclusive placement agent (the “Placement Agent”), pursuant to which the Placement Agent agreed to act as placement agent
on a reasonable “best efforts” basis in connection with the offering. The Company agreed to pay the Placement Agent an aggregate
cash fee equal to 7.5% of the gross proceeds from the sale of securities in the Offering. The Company also agreed to issue
the Placement Agent (or its designees) a warrant (the “Placement Agent Warrant”) to purchase up to 3% of the aggregate
number of shares of Common Stock and Pre-Funded Warrants sold in the Offering, or warrants to purchase up to 19,602 shares of Common
Stock, at an exercise price equal to $6.122 per share. The Placement Agent Warrant is exercisable immediately upon issuance for a period
of five years following the commencement of the sales pursuant to the Offering. In addition, the Company agreed to pay the Placement
Agent $70,000 for fees and expenses of legal counsel and other out-of-pocket expenses.
The
foregoing descriptions of the Placement Agency Agreement, Pre-Funded
Warrant, Warrant, Placement Agent Warrant, Purchase
Agreement, and Registration Rights Agreement are
not complete and are qualified in their entirety by reference to the full text of the form of Placement
Agency Agreement, form of Pre-Funded Warrant,
form of Warrant, form of Placement Agent Warrant, form of Purchase Agreement, and form of Registration
Rights Agreement, copies of which are filed as
Exhibits 1.1, 4.1,
4.2, 4.3, 10.1 and
10.2, respectively,
to this Current Report on Form 8-K and are incorporated by reference herein.
The
legal opinion and consent of Sheppard, Mullin, Richter & Hampton LLP relating to the validity of the securities issued in the Offering
is filed herewith as Exhibit 5.1.
Item
3.02 Unregistered Sales of Equity Securities.
Reference
is made to the disclosure under Item 1.01 above which is hereby incorporated in this Item 3.02 by reference.
The
Warrants and the Placement Agent Warrants and the shares issuable upon exercise of the Warrants and Placement Agent Warrants have not
been registered under the Securities Act of 1933, as amended (the “Securities Act”), or the securities laws of any state,
and are being offered and sold in reliance on the exemption from registration under the Securities Act, afforded by Section 4(a)(2) and/or
Rule 506 promulgated thereunder.
Item
8.01 Other Events.
Press
Releases
On
October 8, 2026, the Company issued a press release announcing the pricing of the Offering. A copy of the press release is furnished
as Exhibit 99.1 to this Form 8-K.
On
October 9, 2026, the Company issued a press release announcing the closing of the Offering. A copy of the press release is furnished
as Exhibit 99.2 to this Form 8-K.
ATM
Agreement
On
October 8, 2026, the Company suspended the use of its prospectus supplement and related prospectus filed with the SEC and dated May 27,
2025, filed as a part of our registration statement on Form S-3 (File No. 333-275608) relating to the At the Market Issuance Sales Agreement,
dated May 22, 2025, or the sales agreement, by and between the Company and the Placement Agent. The Company will not make any sales of
Common Stock pursuant to the sales agreement unless and until a new prospectus supplement is filed with the SEC. Other than the termination
of the prospectus supplement and prospectus relating to the sales agreement, the sales agreement remains in full force and effect.
Item
9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
Number |
|
Description |
| 1.1 |
|
Form of Placement Agency Agreement |
| 4.1 |
|
Form of Pre-Funded Warrant |
| 4.2 |
|
Form of Warrant |
| 4.3 |
|
Form of Placement Agent Warrant |
| 5.1 |
|
Opinion of Sheppard, Mullin, Richter & Hampton LLP |
| 10.1 |
|
Form of Securities Purchase Agreement |
| 10.2 |
|
Form of Registration Rights Agreement |
| 99.1 |
|
Press Release issued by bioAffinity Technologies, Inc., dated October 8, 2026 |
| 99.2 |
|
Press Release issued by bioAffinity Technologies, Inc., dated October 9, 2026 |
| 104 |
|
Cover Page Interactive
Data File (embedded within the XBRL document) |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Current Report on Form 8-K
to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: October 9, 2026 |
BIOAFFINITY
TECHNOLOGIES, INC. |
| |
|
| |
|
| |
By: |
/s/ Maria
Zannes |
| |
Name: |
Maria Zannes |
| |
Title: |
President and Chief
Executive Officer |
Exhibit
99.1
 |
News Release |
bioAffinity
Technologies, Inc. Announces Approximately $4 Million Registered Direct Financing of Common Stock and Concurrent Private Placement Priced
At-The-Market Under Nasdaq Rules
SAN
ANTONIO, Texas (October 8, 2026) – bioAffinity Technologies, Inc. (NASDAQ: BIAF, BIAFW) a biotechnology company
developing noninvasive healthcare solutions for the early detection and monitoring of lung disease, today announced that it has entered
into a definitive agreement with an institutional investor to sell shares of common stock (or pre-funded warrants in lieu thereof) at
a purchase price of $6.122 (or $6.115 per pre-funded warrant), in a registered direct offering priced at-the-market under Nasdaq rules.
Additionally
in a concurrent private placement the Company will sell warrants to purchase up to an aggregate 980,072 shares of common stock at an
exercise price of $6.122 per share. The pre-funded warrants will have an exercise price of $0.007 per share of common stock, and the
warrants will have an exercise price of $6.122 per share, will be exercisable following stockholder approval, and will expire five years
from the date of stockholder approval. The closing of the offering is expected to occur on or about October 9, 2026, subject to the satisfaction
of customary closing conditions.
WallachBeth
Capital, LLC is acting as sole placement agent for the offering.
The
gross proceeds to the Company from the offering are expected to be approximately $4 million before deducting placement agent fees and
other offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital, to
support expected growing sales for CyPath® Lung, its noninvasive test for lung cancer, and general corporate
purposes.
The
common stock described above is being offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File
No. 333-275608) previously filed with the U.S. Securities and Exchange Commission (“SEC”), under the Securities Act of 1933,
as amended (the “Securities Act”), and declared effective by the SEC on November 27, 2023. The offering of the shares of
common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration
statement. A prospectus supplement describing the terms of the proposed registered direct offering and accompanying prospectus will be
filed with the SEC. Electronic copies of the prospectus supplement and accompanying prospectus may be obtained, when available, on the
SEC’s website at https://www.sec.gov or by contacting WallachBeth Capital, LLC, via email at cap-mkts@wallachbeth.com,
by calling +1-646-237-8585, or by standard mail at WallachBeth Capital LLC, Attn: Capital Markets, 185 Hudson St., Suite 1410, Jersey
City, NJ 07311, USA.
This
press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities
in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities
laws of such jurisdiction.
About
bioAffinity Technologies, Inc.
bioAffinity
Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum
cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity,
specificity and accuracy 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. LDTs are overseen under the Clinical
Laboratory Improvement Amendments (CLIA), which are administered by the Centers for Medicare & Medicaid Services. For more information,
visit www.bioaffinitytech.com.
Forward-Looking
Statement
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 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 Company’s ability to close the offering when anticipated, and other factors discussed in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2025, 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.
Contacts
bioAffinity
Technologies
Julie
Anne Overton
Director
of Communications
jao@bioaffinitytech.com
Exhibit
99.2
 |
News Release |
bioAffinity
Technologies, Inc. Announces Closing of $4 Million Registered Direct Financing of Common Stock and Concurrent Private Placement Priced
At-The-Market Under Nasdaq Rules
SAN
ANTONIO, Texas (October 9, 2026) – bioAffinity Technologies, Inc. (NASDAQ: BIAF, BIAFW) a biotechnology company
developing noninvasive healthcare solutions for the early detection and monitoring of lung disease, today announced that it has closed
its previously announced registered direct offering of shares of common stock (or pre-funded warrants in lieu thereof) with an institutional
investor at a purchase price of $6.122 (or $6.115 per pre-funded warrant), in a registered direct offering priced at-the-market
under Nasdaq rules.
Additionally, the Company closed its previously announced concurrent private placement of warrants to purchase up to an aggregate 980,072 shares of common stock at an
exercise price of $6.122 per share. The pre-funded warrants have an exercise price of $0.007 per share of common stock, and the
warrants have an exercise price of $6.122 per share, will be exercisable following stockholder approval, and will expire five years
from the date of stockholder approval.
WallachBeth
Capital, LLC acted as sole placement agent for the offering.
The
gross proceeds to the Company from the offering were approximately $4 million before deducting placement agent fees and other offering
expenses payable by the Company. The Company intends to use the net proceeds from the offering for working capital, to
support expected growing sales for CyPath® Lung, its noninvasive test for lung cancer, and general corporate
purposes.
The
common stock described above was offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File
No. 333-275608) previously filed with the U.S. Securities and Exchange Commission (“SEC”), under the Securities Act of 1933,
as amended (the “Securities Act”), and declared effective by the SEC on November 27, 2023. The offering of the shares of
common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration
statement. A prospectus supplement describing the terms of the proposed registered direct offering and accompanying prospectus will be
filed with the SEC. Electronic copies of the prospectus supplement and accompanying prospectus may be obtained, when available, on the
SEC’s website at https://www.sec.gov or by contacting WallachBeth Capital, LLC, via email at cap-mkts@wallachbeth.com,
by calling +1-646-237-8585, or by standard mail at WallachBeth Capital LLC, Attn: Capital Markets, 185 Hudson St., Suite 1410, Jersey
City, NJ 07311, USA.
This
press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities
in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities
laws of such jurisdiction.
About
bioAffinity Technologies, Inc.
bioAffinity
Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum
cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity,
specificity and accuracy 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. LDTs are overseen under the Clinical
Laboratory Improvement Amendments (CLIA), which are administered by the Centers for Medicare & Medicaid Services. For more information,
visit www.bioaffinitytech.com.
Forward-Looking
Statement
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 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 Company’s ability to close the offering when anticipated, and other factors discussed in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2025, 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.
Contacts
bioAffinity
Technologies
Julie
Anne Overton
Director
of Communications
jao@bioaffinitytech.com