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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): July 23, 2026
Processa
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
001-39531 |
|
45-1539785 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
601
21st Street, Suite 300
Vero
Beach, FL 32960
(Address
of principal executive offices, including zip code)
(772)
453-2899
(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 |
|
Trade
Symbol(s) |
|
Name
of each exchange on which registered |
| Common
Stock, $0.0001 par value per share |
|
PCSA |
|
The
Nasdaq Stock Market LLC |
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 1.01
- Entry into a Material Definitive Agreement.
Agreement
and Plan of Merger
On
July 28, 2026, Processa Pharmaceuticals, Inc., a Delaware corporation (the “Company” or
“Processa”), entered into an Agreement and Plan of Merger (the “Merger
Agreement”), by and among the Company, Venus Merger Sub I, Inc., a Delaware corporation and a wholly owned subsidiary
of the Company (“Merger Sub I”), Venus Merger Sub II, LLC, a Delaware limited liability company and wholly
owned subsidiary of the Company (“Merger Sub II”), and Vidya Therapeutics, Inc., a Delaware corporation
(“Vidya”). Also, on July 28, 2026, the transactions contemplated by the Merger Agreement were
consummated, pursuant to which Merger Sub I merged with and into Vidya, with Vidya surviving and becoming a wholly owned subsidiary
of the Company (the “First Merger”). Immediately following the First Merger, Vidya merged with and into
Merger Sub II, with Merger Sub II surviving and remaining a wholly owned subsidiary of the Company (together with the First Merger,
the “Merger”). The Merger is intended to qualify as a tax-free reorganization for U.S. federal income tax
purposes.
Under
the terms of the Merger Agreement, at the closing of the Merger (the “Closing”), the Company issued to stockholders
of Vidya (i) 558,398 shares of common stock of the Company, par value $0.0001 per share (the “Common Stock”)
and (ii) 142,744.100 shares of Series A Non-Voting Convertible Preferred Stock, par value $0.0001 per share (the “Series A
Preferred Stock”) (as described below), each share of which is to become convertible into 1,000 shares of Common Stock,
subject to approval by the stockholders of the Company of the Preferred Stock Conversion Proposal (as defined below). The powers, preferences,
rights, qualifications, limitations and restrictions applicable to the Series A Preferred Stock are set forth in the Certificate of Designation
(as defined below).
Reference
is made to the discussion of the Series A Preferred Stock in Item 5.03 of this Current Report on Form 8-K, which is incorporated into
this Item 1.01 by reference.
Shares
of Common Stock held by holders thereof immediately prior to the First Effective Time (as defined in the Merger Agreement) remained outstanding
and were unaffected by the Merger. Immediately following the consummation of the Merger but prior to giving effect to the Financing (as
defined below), assuming the conversion of shares of Series A Preferred Stock issued pursuant to the Merger Agreement into shares of
Common Stock (without giving effect to any beneficial ownership limitations), pre-transaction equityholders of the Company held approximately
3% of the issued and outstanding shares of Common Stock and former equityholders of Vidya held approximately 97% of the issued and outstanding
shares of Common Stock, in each case, calculated on a fully-diluted basis and based on the implied equity values of the Company and Vidya.
Following the consummation of the Financing (as defined below), assuming the conversion of the PIPE Securities (as defined below) and
shares of Series A Preferred Stock issued pursuant to the Merger Agreement into shares of Common Stock (in each case, without giving
effect to any beneficial ownership limitations), pre-transaction stockholders of the Company hold approximately 0.9% of
the issued and outstanding shares of Common Stock, former equityholders of Vidya hold approximately 46% of the issued and outstanding
shares of Common Stock and the Investors (as defined below) hold approximately 52.6% of the issued and outstanding shares of Common Stock,
in each case, calculated on a fully-diluted basis and based on the implied equity values of the Company and Vidya.
Pursuant
to the terms of the Merger Agreement, each option to purchase Vidya common stock was assumed by the Company and converted into an option
to purchase Common Stock (each, a “Parent Assumed Option”), which options are subject to exercise restrictions
prior to obtaining the approval of the Parent Stockholder Matters (as defined below).
Pursuant
to the Merger Agreement and the Purchase Agreement (as defined below), the Company has agreed to hold a stockholders’ meeting (the
“Stockholders’ Meeting”) to submit the following matters to its stockholders for their consideration: (i) the approval
in accordance with applicable rules of the Nasdaq Stock Market, LLC (the “Nasdaq”) of the conversion of the
Series A Preferred Stock (including the Series A Preferred Stock issued in the Financing (as defined below)) into shares of Common Stock
(the “Preferred Stock Conversion Proposal”), (ii) the approval of a 2026 Equity Incentive Plan, subject to
approval by the board of directors of the Company (the “Board”), (iii) the approval of a 2026 Employee Stock
Purchase Plan, and (iv) to the extent deemed necessary or advisable by the Company and/or Vidya, approval of an amendment to the Company’s
certificate of incorporation to effect a reverse stock split (the matters contemplated in items (i) through (iv) collectively, the “Parent
Stockholder Matters”). In connection with the Parent Stockholder Matters, the Company intends to file with the Securities
and Exchange Commission (the “SEC”) a proxy statement and other relevant materials. Holders of shares of Common
Stock issued pursuant to the Merger Agreement and Parent Assumed Options will not be entitled to vote such shares in connection with
the Preferred Stock Conversion Proposal in accordance with Rule 5635 of the listing rules of Nasdaq and as provided in the Merger Agreement.
Pursuant
to the Merger Agreement, as promptly as practicable following the closing date of the Merger (and in any event not later than 75 days
following the closing of the Financing), the Company has agreed to prepare and file with the SEC a Registration Statement on Form S-3
(or, if Form S-3 is not then available to the Company, on such form of registration statement as is then available) to register the resale
of (i) the shares of Common Stock issued pursuant to the Merger Agreement and (ii) the shares of Common Stock underlying the Series A
Preferred Stock issued pursuant to the Merger Agreement.
The
Board unanimously approved the Merger Agreement and the related transactions, and the consummation of the Merger did not require the
approval of the Company’s stockholders.
The
foregoing description of the Merger and the Merger Agreement does not purport to be complete and is qualified in its entirety by reference
to the Merger Agreement, which is filed as Exhibit 2.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Support
Agreements
In
connection with the execution of the Merger Agreement, the Company and Vidya entered into stockholder support agreements (the “Support
Agreements”) with all of the Company’s officers and directors (solely in their capacity as stockholders). The Support Agreements provide that, among other things, each of
the parties thereto has agreed to vote or cause to be voted all of the shares of Common Stock owned by such stockholder in favor of the
Parent Stockholder Matters at the Stockholders’ Meeting to be held in connection therewith, subject to and in accordance with the
terms of the Support Agreements.
The
foregoing description of the Support Agreements does not purport to be complete and is qualified in its entirety by reference to the
form of the Support Agreement, which is provided as Exhibit D to the Merger Agreement, which is filed as Exhibit 2.1 to this Current
Report on Form 8-K and incorporated herein by reference.
Lock-Up
Agreements
Concurrently
and in connection with the execution of the Merger Agreement, certain officers, directors and stockholders of Vidya, and all of
the directors and officers of the Company entered into lock-up agreements with the Company, pursuant to which each such person is subject
to a 180-day lock-up on the sale or transfer of shares of Common Stock and Series A Preferred Stock held by each such person at the Closing,
including, in the case of the specified officers, directors and stockholders of Vidya, those shares received by them in the Merger (the
“Lock-Up Agreements”).
The
foregoing description of the Lock-Up Agreements does not purport to be complete and is qualified in its entirety by reference to the
form of Lock-Up Agreement, which is provided as Exhibit C to the Merger Agreement, which is filed as Exhibit 2.1 to this Current Report
on Form 8-K and incorporated herein by reference.
Securities
Purchase Agreement for Private Placement of Securities
On
July 28, 2026, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with
the investors named therein (the “Investors”).
Pursuant
to the Purchase Agreement, the Company agreed to sell an aggregate of 163,774.679 shares of Series A Preferred Stock (the “PIPE
Securities”) for an aggregate cash purchase price of approximately $200.0 million (collectively, the “Financing”). The Company intends to use the net proceeds to fund operations into the second half
of 2029 and through key clinical milestones, including top-line data from Phase 2 proof-of-concept studies for food allergy, chronic
spontaneous urticaria (CSU), and relapsing multiple sclerosis (RMS).
The
closing of the Financing is expected to occur on July 30, 2026 (the “Financing Closing Date”), subject to the satisfaction
of customary conditions to closing.
The
foregoing summary of the Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the Purchase
Agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K.
Registration
Rights Agreement
In
connection with the closing of the Financing, the Company entered into a Registration Rights Agreement (the
“Registration Rights Agreement”) with the Investors. Pursuant to the Registration Rights Agreement, the
Company is required to prepare and file a resale registration statement with the SEC within 75 calendar days following the Financing
Closing Date. The Company is obligated to use its reasonable best efforts to cause this registration statement to be declared
effective by the SEC within five business days of the date the Company is notified by the SEC that the registration statement will
not be reviewed or will not be subject to further review (or within 60 calendar days following the filing deadline if the SEC
reviews the registration statement).
The
Company has also agreed to, among other things, indemnify the Investors, their officers, directors, members, employees, partners, managers,
stockholders, affiliates, investment advisors and agents under the registration statement from certain liabilities and pay all fees and
expenses (excluding any legal fees of the selling holder(s), and any underwriting discounts and selling commissions) incident to the
Company’s obligations under the Registration Rights Agreement.
The
foregoing summary of the Registration Rights Agreement does not purport to be complete and is qualified in its entirety by reference
to the form of Registration Rights Agreement, which is filed as Exhibit 10.2 to this Current Report on Form 8-K.
The
Merger Agreement and the Securities Purchase Agreement have been included to provide investors and security holders with information
regarding their terms. They are not intended to provide any other factual information about the Company or Vidya. Each of the Merger
Agreement and the Securities Purchase Agreement contain representations, warranties and covenants that the parties thereto made to each
other as of specific dates. The assertions embodied in those representations, warranties and covenants were made solely for purposes
of the Merger Agreement and the Securities Purchase Agreement, respectively, between the parties thereto and may be subject to important
qualifications and limitations agreed to by the parties thereto in connection with negotiating its terms, including being qualified by
confidential disclosures exchanged between the parties in connection with the execution of each of the Merger Agreement and the Securities
Purchase Agreement. Moreover, the representations and warranties may be subject to a contractual standard of materiality that may be
different from what may be viewed as material to investors or securityholders, or may have been used for the purpose of allocating risk
between the parties thereto, rather than establishing matters as facts. Moreover, information concerning the subject matter of the representations
and warranties may change after the date of the Merger Agreement and the Securities Purchase Agreement, which subsequent information
may or may not be fully reflected in the Company’s public disclosures. For the foregoing reasons, no person should rely on the
representations and warranties as statements of factual information at the time they were made or otherwise.
Item
1.02 – Termination of a Material Definitive Agreement.
On
July 23, 2026, the Company terminated its License Agreement, dated August 23, 2020 (the “Elion License Agreement”),
with Elion Oncology, Inc. (“Elion”) to commercialize PCS6422, which is also referred to as NGC-Cap and was
the Company’s only Next Generation cancer therapy that had reached a Phase 2 trial, by entering into a settlement (the “Settlement”)
with Elion. Pursuant to the Settlement, the parties agreed to settle all claims in respect of their litigation regarding the Elion License
Agreement and to terminate the Elion License Agreement without further obligation of either party, with the Company returning the PCS6422
program to Elion. In connection with the Settlement, the parties exchanged mutual releases of all claims relating to the Elion License
Agreement, the PCS6422 program and the related litigation. As part of the Settlement, the Company will pay Elion the sum of $650,000
towards Elion’s attorneys’ fees and/or other out-of-pocket costs. In addition, the Company agreed to grant to Elion a non-voting
equity interest equal to seven and one-half percent (7.5%) of the fully diluted pre-money equity capitalization of any newly formed entity
(“NewCo”) whose assets include one or more of PCS499, PCS11-T and/or PCS12852, if the formation or spin-out
of NewCo is completed within three hundred sixty-five (365) days following the effective date of the Settlement Agreement.
The
Company intends to continue to develop PCS499, a drug that can be used to treat unmet medical need conditions caused by multiple pathophysiological
changes. The Company also continues to have PCS11T and PCS12852 in its drug pipeline.
Item
2.01 - Completion of Acquisition or Disposition of Assets.
On
July 28, 2026, the Company completed its acquisition of Vidya pursuant to the Merger Agreement. The information contained in Item
1.01 of this Current Report on Form 8-K is incorporated by reference into this Item 2.01.
Item 3.02
- Unregistered Sales of Equity Securities.
The
information contained in Item 1.01 of this Current Report on Form 8-K is incorporated by reference into this Item 3.02. The PIPE Securities
to be issued and sold on the Financing Closing Date and shares of Common Stock and Series A Preferred Stock issued pursuant to the Merger
Agreement were offered and sold in transactions exempt from registration under the Securities Act, in reliance on Section 4(a)(2) thereof.
Each of the Investors represented that it was an “accredited investor,” as defined in Regulation D, and is acquiring the
PIPE Securities for investment only and not with a view towards, or for resale in connection with, the public sale or distribution thereof.
In the Merger Agreement and written consent of Vidya’s stockholders, Vidya and its stockholders also made representations regarding
the knowledge and experience in financial and business matters and investment intent of Vidya’s stockholders. The PIPE Securities
and shares of Common Stock and Series A Preferred Stock issued pursuant to the Merger Agreement have not been registered under the Securities
Act and such securities may not be offered or sold in the United States absent registration or an exemption from registration under the
Securities Act and any applicable state securities laws. Neither this Current Report on Form 8-K nor any of the exhibits attached hereto
constitutes an offer to sell or the solicitation of an offer to buy shares of Common Stock, shares of Series A Preferred Stock or any
other securities of the Company.
Item 5.02
- Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain
Officers.
Appointment
of Directors
In
accordance with the Merger Agreement, on July 28, 2026, effective immediately after the First Effective Time, Sheila Gujrathi
was appointed to the Board as a director.
Sheila
Gujrathi, M.D., age 55, has served as a member of our board of directors since July 2026. Dr. Gujrathi founded Vidya and served as
its Executive Chair of the board of directors of Vidya from March 2023 until the Acquisition. She has served as founder and Chief Executive
Officer of Prana Therapies since March 2023, and as founder and Executive Chair of the board of directors of Lila Biologics, Inc., a
privately held biopharmaceutical company, since March 2023. Dr. Gujrathi has served as a member of the boards of directors of BlossomHill
Therapeutics, Inc., a publicly held biopharmaceutical company, since May 2026, and Janux Therapeutics, Inc., a publicly held biopharmaceutical
company, since March 2021. She has also served as Executive Chair of the board of directors of Generian Pharmaceuticals, Inc., a privately
held biotechnology company, since May 2023. She previously served as Executive Chair of the board of directors of Ventyx Biosciences,
Inc., a publicly held biopharmaceutical company, from May 2021 until its acquisition by Eli Lilly and Company in January 2026, chair
of the board of directors of ADARx Pharmaceuticals, Inc., a privately held biopharmaceutical company, from June 2020 to January 2025,
chair of the board of directors of ImmPACT Bio USA Inc., a privately held biotechnology company, from December 2021 until its acquisition
by Lyell Immunopharma, Inc. in October 2024, a member of the board of directors of Turning Point Therapeutics, Inc. (acquired by Bristol-Myers
Squibb Company in August 2022), a then-publicly held biopharmaceutical company, from November 2017 to March 2021, and chair of the board
of directors of Turning Point from April 2019 to March 2021. Dr. Gujrathi previously served as a member of the board of directors of
Five Prime Therapeutics, Inc. (acquired by Amgen, Inc. in April 2021) from December 2015 to June 2019 and as a member of the board of
directors of Ambrx, Inc., a then-publicly held biopharmaceutical company, from February 2014 until its acquisition by Johnson & Johnson
in June 2015. Dr. Gujrathi is a Co-Founder of Gossamer Bio, Inc., a publicly held biopharmaceutical company, and served as its President
and Chief Executive Officer from July 2018 to November 2020 and as its President and Chief Operating Officer from October 2015 to June
2018 and as a member of its board of directors from October 2015 to November 2020. Previously, Dr. Gujrathi was the Chief Medical Officer
of Receptos, Inc., a then-publicly held biopharmaceutical company, a position she held from June 2011 until its acquisition by Celgene
Corporation in August 2015. Previously, Dr. Gujrathi worked at Bristol-Myers Squibb Company, where she served as Vice President of the
Global Clinical Research Group in Immunology from August 2008 to June 2011. Previously, Dr. Gujrathi worked at Genentech, Inc., where
she held roles of increasing responsibility in the Immunology, Tissue Growth and Repair clinical development group from October 2002
to July 2008. From 1999 until 2002, Dr. Gujrathi was a management consultant at McKinsey & Company in the healthcare practice, where
she provided strategic advice on a variety of projects in the healthcare and pharmaceutical industry. Dr. Gujrathi received her B.S.
in biomedical engineering and M.D. from Northwestern University. Dr. Gujrathi completed her internal medicine internship and residency
at Brigham and Women’s Hospital, Harvard Medical School and is board certified in internal medicine. Dr. Gujrathi received additional
training at the University of California, San Francisco and Stanford University in their Allergy and Immunology Fellowship Program.
We
believe that Dr. Gujrathi is qualified to serve on our board of directors based on her leadership as Vidya’s Executive Chair and
her extensive experience as a leader in the biopharmaceutical industry, including as a board member of multiple biotechnology and biopharmaceutical
companies.
Except
as described in the Merger Agreement, there are no arrangements or understandings between Ms. Gujrathi and any other person pursuant
to which she was appointed as a director of the Company. Except as described below, Ms. Gujrathi is not a party to any transaction required
to be disclosed pursuant to Item 404(a) of Regulation S-K.
Item
5.03 - Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.
On
July 28, 2026, the Company filed with the Secretary of State of the State of Delaware a Certificate of Designation of Preferences,
Rights and Limitations of the Series A Preferred Stock (the “Certificate of Designation”) in connection with
the Merger and the Financing referenced in Item 1.01 above. The Certificate of Designation provides for the creation of the Company’s
Series A Preferred Stock.
Holders
of Series A Preferred Stock are entitled to receive dividends on shares of Series A Preferred Stock equal to, on an as-if-converted-to-Common-Stock
basis, and in the same form as dividends actually paid on shares of the Common Stock. Except as otherwise provided in the Certificate
of Designation or as otherwise required by the General Corporation Law of the State of Delaware, the Series A Preferred Stock shall have
no voting rights. However, as long as any shares of Series A Preferred Stock are outstanding, the Company shall not, without the affirmative
vote of the holders of a majority of the then outstanding shares of the Series A Preferred Stock: (i) alter or change adversely the powers,
preferences or rights given to the Series A Preferred Stock or alter or amend the Certificate of Designation, amend its certificate of
incorporation or other charter documents in any manner that adversely affects any rights of the holders of Series A Preferred Stock,
(ii) issue additional shares of Series A Preferred Stock or increase or decrease (other than by conversion) the number of authorized
shares of Series A Preferred Stock, (iii) prior to the Automatic Conversion (as defined below), consummate either: (A) any Fundamental
Transaction (as defined in the Certificate of Designation) or (B) any merger or consolidation of the Company with or into another Person
or any stock sale to, or other business combination (including, without limitation, a reorganization, recapitalization, spin-off, share
exchange or scheme of arrangement) with or into, another Person in which the stockholders of the Company immediately before such transaction
do not hold at least a majority of the voting power of the capital stock of the Company or surviving corporation or the parent entity
of the Company or surviving corporation immediately after such transaction or in which the Company or the surviving corporation issues
securities in such transaction that represent, or are convertible into securities representing, more than a majority of the voting power
of the Company immediately before such transaction, (iv) prior to the stockholder approval of the Preferred Stock Conversion Proposal,
authorize or issue any class or series of stock that has powers, preferences or rights that are senior to those of the Series A Preferred
Stock, (v) amend, waive or modify the Merger Agreement in any manner that would be reasonably likely to prevent, impede or materially
delay stockholder approval of the Preferred Stock Conversion Proposal or the Automatic Conversion (as defined below) or (vi) enter into
any agreement with respect to any of the foregoing.
At
5:00 pm Eastern time on the third business day following stockholder approval of the Preferred Stock Conversion Proposal, each share
of Series A Preferred Stock will automatically convert into 1,000 shares of Common Stock (the “Automatic Conversion”),
subject to certain limitations, including that a holder of Series A Preferred Stock is prohibited from converting shares of Series A
Preferred Stock into shares of Common Stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially
own more than a specified percentage (to be established by the holder between 4.9% and 19.9%) of the total number of shares of Common
Stock issued and outstanding immediately after giving effect to such conversion (the “Beneficial Ownership Limitation”);
provided that following stockholder approval of the Preferred Stock Conversion Proposal, such Beneficial Ownership Limitation may be
waived by each holder of Series A Preferred Stock upon written notice to the Company to be effective on the 61st day following receipt
of such notice.
If
at any time after the earlier of (i) the Stockholder Approval or (ii) nine months after the initial issuance of the Series A Preferred
Stock, the Company fails to deliver to the holder of the Series A Preferred Stock shares of Common Stock underlying such shares of Series
A Preferred Stock, then (other than in certain circumstances set forth in the Certificate of Designation), the Company will pay, at the
request of such holder, an amount of cash by wire transfer of immediately available funds equal to the Fair Value (as defined in the
Certificate of Designation) of such undelivered shares, provided that the Company has funds legally available for such payment.
The
foregoing description of the Series A Preferred Stock does not purport to be complete and is qualified in its entirety by reference to
the Certificate of Designation, a copy of which is filed as Exhibit 3.1 to this Current Report on Form 8-K and is incorporated herein
by reference.
Item
7.01 - Regulation FD Disclosure.
On
July 29, 2026, the Company issued a press release related to the Merger and the Financing, and made available Vidya’s investor
presentation to be used in general corporate communications and investor communications. Copies of the press release and presentation
are furnished as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report on Form 8-K.
The
information in Item 7.01 of this Current Report on Form 8-K, including the information in the press release attached as Exhibit 99.1
and the presentation attached as Exhibit 99.2 to this Current Report on Form 8-K, is furnished pursuant to Item 7.01 of Form 8-K and
shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise
subject to the liabilities of that section. Furthermore, the information in Item 7.01 of this Current Report on Form 8-K, including Exhibit
99.1 and Exhibit 99.2 to this Current Report on Form 8-K, shall not be deemed to be incorporated by reference in the filings of the Company
under the Securities Act.
Forward
Looking Statements
Certain
statements contained in this Form 8-K may constitute forward-looking statements within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words and phrases “designed to,”
“may,” “might,” “can,” “will,” “to be,” “could,” “would,”
“should,” “expect,” “intend,” “plan,” “objective,” “anticipate,”
“believe,” “estimate,” “predict,” “project,” “potential,” “likely,”
“continue,” “ongoing” or similar expressions, or the negative of such words, are intended to identify “forward-looking
statements.” These forward-looking statements include, but are not limited to, statements regarding the Company, Vidya, the Financing
and the Merger, including the closing of the Financing, if any, and the expected effects, perceived benefits or opportunities and related
timing with respect thereto; expectations regarding or plans for the combined company’s pipeline, including its ongoing clinical
trials and research and development programs; and expectations regarding the use of proceeds from the Financing and cash runway expectations
therefrom, including such proceeds funding the combined company through key clinical milestones and the expected timing of such milestones.
The Company has based these forward-looking statements on its current expectations and projections about future events. Because such
statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking
statements. Factors that could cause or contribute to these differences include those above in this Current Report on Form 8-K and in
the Company’s other filings with the SEC. Statements made herein are as of the date of the filing of this Current Report on Form
8-K with the SEC and should not be relied upon as of any subsequent date. Unless otherwise required by applicable law, the Company does
not undertake, and it specifically disclaims, any obligation to update any forward-looking statements to reflect occurrences, developments,
unanticipated events or circumstances after the date of such statement.
Item
9.01 - Financial Statements and Exhibits.
(a)
Financial statements of business acquired
The
financial statements required by this Item 9.01(a) are not included in this Current Report on Form 8-K. The Company intends to include
such financial statements by amendment to this Current Report on Form 8-K no later than 71 calendar days after the date this Current
Report on Form 8-K is required to be filed.
(b)
Pro forma financial information
The
pro forma financial information required by this Item 9.01(b) is not included in this Current Report on Form 8-K. The Company intends
to include such pro forma financial information by amendment to this Current Report on Form 8-K no later than 71 calendar days after
the date this Current Report on Form 8-K is required to be filed.
(d)
Exhibits
Exhibit
Number |
|
Description |
| |
|
| 2.1* |
|
Agreement and Plan of Merger, dated July 28, 2026, by and among Processa Pharmaceuticals, Inc., Venus Merger Sub I, Inc., Venus Merger Sub II, LLC and Vidya Therapeutics, Inc. |
| |
|
| 3.1 |
|
Certificate of Designation of Series A Non-Voting Convertible Preferred Stock |
| |
|
| 10.1* |
|
Form of Securities Purchase Agreement, dated as of July 28, 2026, by and among Processa Pharmaceuticals, Inc. and each investor listed on Exhibit A thereto |
| |
|
| 10.2 |
|
Form of Registration Rights Agreement, by and among Processa Pharmaceuticals, Inc. and the investors signatory thereto |
| |
|
| 99.1 |
|
Press Release issued on July 29, 2026 (furnished herewith) |
| |
|
|
| 99.2 |
|
Investor Presentation, dated July 29, 2026 (furnished herewith) |
| |
|
| 104 |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL document) |
| * |
Certain
schedules and attachments have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company agrees to provide, on a
supplemental basis, a copy of any omitted schedules and attachments to the Securities and Exchange Commission or its staff upon
request. |
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.
|
Processa
Pharmaceuticals, Inc. |
| |
|
|
| Date:
July 29, 2026 |
By: |
/s/
Russell Skibsted |
| |
Name: |
Russell Skibsted |
| |
Title: |
Chief Financial Officer |
Exhibit
99.1
PROCESSA
PHARMACEUTICALS, INC. ANNOUNCES ACQUISITION OF VIDYA THERAPEUTICS, INC. AND APPROXIMATELY $200 MILLION CONCURRENT PRIVATE PLACEMENT TO
ADVANCE BTK INHIBITOR, VT-7208, IN MULTIPLE DISEASE AREAS
| ● | Acquisition
brings into Processa’s pipeline Vidya’s lead asset, VT-7208, a next-generation,
CNS-penetrant, once-daily, oral potentially best-in-class Bruton’s tyrosine kinase
inhibitor (BTKi) designed to overcome the efficacy and safety limitations of early-generation
BTKi programs |
| | | |
| ● | Concurrent
oversubscribed private placement financing of approximately $200 million committed by a syndicate
of leading healthcare institutional investors and mutual funds |
| | | |
| ● | Private
placement proceeds are expected to fund operations into the second half of 2029 and through
key clinical milestones, including top-line data from Phase 2 proof-of-concept studies for
food allergy, chronic spontaneous urticaria (CSU), and relapsing multiple sclerosis (RMS) |
| | | |
| ● | Processa
to host investor webcast on July 29, 2026, at 8:30 a.m. ET |
VERO
BEACH, FL, JULY 29, 2026 – Processa Pharmaceuticals, Inc. (Processa) (Nasdaq: PCSA) today announced it has acquired Vidya Therapeutics,
Inc. (Vidya), a clinical-stage biotechnology company developing VT-7208, a Bruton’s tyrosine kinase (BTK) inhibitor therapy for
immune-mediated diseases with an initial focus on potentially best-in-class BTK inhibition in food allergy, chronic spontaneous urticaria
and relapsing multiple sclerosis.
Concurrent
with the acquisition, Processa entered into a definitive agreement for a private placement financing expected to result in gross proceeds
of approximately $200 million, before deducting placement agent and other offering expenses, from a syndicate of new and existing investors,
including Bain Capital Life Sciences, Janus Henderson Investors, RA Capital Management, SilverArc Capital, ADAR1 Capital Management,
Cormorant Asset Management, Integral Health Asset Management, Marshall Wace, Octagon Capital, Soleus Capital, a large mutual fund, and
other institutional investors.
Processa
expects to use the proceeds to support the advancement of VT-7208 through multiple clinical milestones, including data from a Phase 2
proof-of-concept study in food allergy anticipated in the second half of 2027, data from a Phase 2 proof-of-concept study in CSU anticipated
in the first half of 2028, and data from a Phase 2 proof-of-concept study in RMS anticipated in the second half of 2028. The company’s
cash and cash equivalents at closing, including gross proceeds expected from the concurrent private placement financing, are expected
to fund operations into the second half of 2029.
“We’re
thrilled to have the backing of a stellar group of healthcare investors who see the value in Vidya’s VT-7208 and share our vision
for where it can go. This transaction gives us the capital to evaluate VT-7208’s potential, running our food allergy, CSU and RMS
programs in parallel rather than sequentially,” said Sheila Gujrathi, M.D., Founder & Executive Chair of Vidya and newly appointed
Board Director of Processa.
“This
transaction with Vidya represents a compelling opportunity to create meaningful value for our shareholders through the acquisition of
a differentiated, clinical-stage BTK inhibitor program with the potential to address significant unmet needs across multiple disease
areas,” said George Ng, Chief Executive Officer of Processa.
ABOUT
VT-7208
VT-7208
is a next-generation, CNS-penetrant, covalent BTKi designed to achieve potent, highly selective and durable BTK inhibition with preclinical
and Phase 1 data that supports using lower doses than earlier BTKi’s. VT-7208’s selectivity profile was also designed to
minimize off-target kinase activity, which Vidya believes may reduce hepatotoxicity risk relative to earlier BTKi’s.
BTK
is a validated node in B-cell activation, mast cell signaling and innate immune function, implicating it across autoimmune, allergic
and neuroinflammatory diseases. Vidya believes VT-7208’s dual peripheral and CNS activity positions it to modulate a broad range
of diseases. Processa expects to initiate Phase 2 studies in food allergy and CSU in the second half of 2026, and in RMS in the first
half of 2027, with multiple anticipated clinical milestones across the pipeline expected over the next 12–24 months.
In
a Phase 1 clinical trial, at low milligram doses administered once-daily, VT-7208 demonstrated robust and sustained target engagement,
validating signaling pathway modulation, the potential for durable pharmacodynamic activity, and predictable, dose-dependent pharmacokinetics
in both the CSF and periphery. In the same study, no serious adverse events were observed, and VT-7208 was generally well-tolerated.
ABOUT
THE TRANSACTION
The
acquisition is structured as a stock-for-stock transaction, pursuant to which all outstanding equity interests of Vidya will be exchanged
based on a fixed exchange ratio for a combination of 558,398 shares of Processa common stock, 142,744.100 shares of Series A non-voting
convertible preferred stock (representing 142,744,100 shares of Processa common stock on an as-converted basis and without giving
effect to any beneficial ownership limitations).
Concurrent
with the acquisition, Processa entered into a definitive agreement for a private placement financing to raise approximately $200 million
in gross proceeds, in which the investors will be issued 163,774.679 shares of Series A non-voting convertible preferred stock (or 163,774,679.00
shares of Processa common stock on an as-converted basis and without giving effect to any beneficial ownership limitations) at a price
of $1,221.19 per share (or $1.22119 per share on an as-converted basis). The private placement is expected to close on July 30, 2026.
Subject
to Processa stockholder approval in accordance with Nasdaq listing rules, each share of Series A non-voting convertible preferred stock
will automatically convert into 1,000 shares of Processa common stock, subject to certain beneficial ownership limitations set by each
holder.
The
acquisition was approved by the Board of Directors of Processa and the Board of Directors and stockholders of Vidya. The closings of
the acquisition and the private placement are not subject to the approval of Processa’s stockholders. The approval of Processa’s
stockholders is required, among other things, under the terms of the Series A non-voting convertible preferred stock in order for the
Series A non-voting convertible preferred stock to be converted into shares of Processa’s common stock, and Processa is required
to hold a stockholder meeting for such vote. As a result of the transactions, stockholders of Processa immediately prior to the
acquisition will own approximately 0.9% of Processa’s common stock, equity holders of Vidya immediately prior to the acquisition
will own approximately 46.0% of Processa common stock and investors in the private placement financing will own approximately 52.6% of
Processa common stock, in each case, calculated on a fully-diluted basis (without giving effect to any beneficial ownership limitations
and assuming the conversion in full of the Series A non-voting convertible preferred stock) and based on the implied equity values of
Processa and Vidya. Following the closing of the private placement, Processa is expected to have projected cash runway into the second
half of 2029.
Leerink
Partners is serving as exclusive financial advisor to Vidya and as lead placement agent for the concurrent private placement financing.
Evercore ISI, UBS Investment Bank and Wells Fargo Securities are serving as co-placement agents for the concurrent private placement
financing. Tungsten Advisors is serving as financial advisor to Processa and provided a fairness opinion to Processa’s board of
directors. Cooley LLP is serving as legal counsel to Vidya. Katten Muchin Rosenman LLP is serving as legal counsel to Processa. Mintz,
Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is serving as legal counsel to the placement agents.
WEBCAST
INFORMATION AND COMPANY PRESENTATION
Wednesday, July 29, 2026 @ 8:30
a.m. ET
Webcast:
Click Here
A
replay of the webcast presentation will be temporarily archived on the Investors section of the company’s website following the
presentation.
ABOUT
VIDYA
Vidya
is a clinical-stage biotechnology company developing a Bruton’s tyrosine kinase (BTK) inhibitor therapy for immune-mediated diseases.
The company is advancing a potentially best-in-class BTK inhibitor (BTKi) designed to improve on the efficacy and safety of early-generation
programs. Vidya has three parallel development programs: food allergy and chronic spontaneous urticaria (CSU) in immunology, and relapsing
multiple sclerosis (RMS) in neurology, where its CNS-penetrant profile addresses an area of high unmet need. With Phase 1 complete, the
company intends to advance all three programs toward Phase 2 proof-of-concept studies, with initial data expected in 2027 and 2028.
ABOUT
PROCESSA
Processa
is a clinical-stage pharmaceutical company advancing innovative drug candidates through a disciplined, science-driven development strategy.
By combining more than 30 years of drug development expertise with its proprietary Regulatory Science Approach, Processa designs efficient
clinical programs focused on identifying optimal dosing, strengthening the benefit-risk profile, and improving the likelihood of regulatory
success.
The
Processa team has contributed to more than 30 regulatory approvals across numerous divisions of the U.S. Food and Drug Administration.
Its development approach integrates pharmacokinetics, metabolism, safety, efficacy, and dose-response data to establish an Optimal Dosage
Regimen for each candidate, with the goal of delivering meaningful treatment options to patients through efficient and scientifically
supported regulatory pathways.
In
addition to advancing the clinical-stage BTK inhibitor program, Processa intends to continue the development of its legacy pharmaceutical
assets, including PCS499 and PCS12852, while evaluating strategic opportunities designed to maximize their clinical and long-term value.
FORWARD-LOOKING
STATEMENTS
Certain
statements in this press release, other than purely historical information, may constitute “forward-looking statements” within
the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities
Litigation Reform Act of 1995, concerning Processa, Vidya, the concurrent private placement financing and the acquisition of Vidya by
Processa (the “Transactions”) and other matters. These forward-looking statements include, but are not limited to, express
or implied statements relating to the company’s expectations, hopes, beliefs, intentions or strategies regarding the future including,
without limitation, statements regarding: the Transactions, including the closing of the concurrent private placement financing, if any,
and the expected effects, perceived benefits or opportunities and related timing with respect thereto; expectations regarding or plans
for the Processa’s pipeline, including its ongoing clinical trials, research and development programs and the expected timing for
key milestones, including the release of clinical data; the potential benefits of VT-7208; and expectations regarding the use of proceeds
from the concurrent private placement financing and cash runway expectations therefrom, including such proceeds funding the company through
key clinical milestones. In addition, any statements that refer to projections, forecasts or other characterizations of future events
or circumstances, including any underlying assumptions, are forward-looking statements. The words “opportunity,” “potential,”
“milestones,” “pipeline,” “can,” “goal,” “aim,” “strategy,” “target,”
“seek,” “anticipate,” “achieve,” “believe,” “contemplate,” “continue,”
“could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,”
“possible,” “predict,” “project,” “should,” “will,” “would” and
similar expressions (including the negatives of these terms or variations of them) may identify forward-looking statements, but the absence
of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations
and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting
the company or the Transactions will be those that have been anticipated. These forward-looking statements involve a number of risks,
uncertainties (some of which are beyond the company’s control) or other assumptions that may cause actual results or performance
to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include,
but are not limited to those uncertainties and factors described under the heading “Risk Factors” and in the company’s
most recent Annual Report on Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2026,
as well as discussions of potential risks, uncertainties, and other important factors included in other filings by the company from time
to time, as well as risk factors associated with companies, such as Vidya, that operate in the biotechnology industry. Should one or
more of these risks or uncertainties materialize, or should any of the company’s assumptions prove incorrect, actual results may
vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded
as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated
results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this
press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements
herein. The company does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements.
This press release does not purport to summarize all of the conditions, risks and other attributes of an investment in the company.
CONTACTS
Vidya
Therapeutics
Media
Ryan
Flinn
The
Grace Group
ryan@gracegroup.us
General
Inquiries
info@vidyatx.com