Item 7.01. Regulation FD Disclosure.
As previously disclosed, on June 5, 2022, Yumanity Therapeutics, Inc., a
Delaware corporation ("Yumanity"), entered into an Asset Purchase Agreement (the
"Asset Purchase Agreement") with Janssen Pharmaceutica NV ("Janssen").
Concurrently with the execution of the Asset Purchase Agreement, on June 5,
2022, Yumanity entered into an Agreement and Plan of Merger with Kineta, Inc., a
Washington corporation ("Kineta"), and Yacht Merger Sub, Inc., a Washington
corporation and wholly-owned subsidiary of Yumanity.
On November 15, 2022, Kineta issued a press release announcing that the U.S.
Food and Drug Administration has accepted its Investigational New Drug
application to evaluate its VISTA blocking immunotherapy, KVA12123 (formerly
referred to as KVA12.1), as a potential treatment for patients with advanced
solid tumors. Kineta is planning to conduct a Phase 1/Phase 2 clinical study
evaluating KVA12123 as a single agent and in combination with pembrolizumab in
patients with advanced solid tumors. A copy of the press release is attached
hereto as Exhibit 99.1.
The information in this Item 7.01, including Exhibit 99.1 attached hereto, is
being furnished and shall not be deemed "filed" for purposes of Section 18 of
the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or
otherwise subject to the liabilities of that section, and shall not be deemed
incorporated by reference in any filing under the Securities Act of 1933, as
amended (the "Securities Act"), or the Exchange Act, except as expressly set
forth by specific reference in such a filing.
Important Information and Where to Find It
This communication may be deemed to be solicitation material with respect to the
proposed transactions between Yumanity and Kineta and between Yumanity and
Janssen. In connection with the proposed transactions, on August 29, 2022,
Yumanity filed with the U.S. Securities and Exchange Commission (the "SEC") a
registration statement on Form S-4 (the "Initial Registration Statement"), as
amended by Amendment No. 1 to the Initial Registration Statement filed with the
SEC on October 3, 2022, Amendment No. 2 to the Initial Registration Statement
filed with the SEC on October 24, 2022 and Amendment No. 3 to the Initial
Registration Statement filed with the SEC on November 4, 2022 (together with the
Initial Registration Statement, the "Registration Statement"), which contains a
preliminary proxy statement and prospectus. The Registration Statement has been
declared effective by the SEC on November 10, 2022. Yumanity subsequently filed
the definitive proxy statement/prospectus (the "Proxy Statement") on
November 10, 2022, which is being mailed to stockholders of record as of the
close of business on November 4, 2022. Investors and securityholders of Yumanity
and Kineta are urged to read these materials when they become available because
they contain important information about Yumanity, Kineta and the proposed
transactions. This communication is not a substitute for the Registration
Statement, the Proxy Statement or any other documents that Yumanity may file
with the SEC or send to securityholders in connection with the proposed
transactions. Investors
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and securityholders may obtain free copies of the documents filed with the SEC,
once available, on Yumanity's website at www.yumanity.com, on the SEC's website
at www.sec.gov or by directing a request to Yumanity's Investor Relations at
(212) 213-0006 ext. 331.
This communication shall not constitute an offer to sell or the solicitation of
an offer to sell or the solicitation of an offer to buy any securities, nor
shall there be any sale of securities in any jurisdiction in which such offer,
solicitation or sale would be unlawful prior to registration or qualification
under the securities laws of any such jurisdiction. No offering of securities
shall be made except by means of a prospectus meeting the requirements of
Section 10 of the Securities Act.
Participants in the Solicitation
Each of Yumanity, Kineta and their respective directors and executive officers
may be deemed to be participants in the solicitation of proxies from the
stockholders of Yumanity in connection with the proposed transactions.
Information about the executive officers and directors of Yumanity is set forth
in Yumanity's Definitive Proxy Statement on Schedule 14A relating to the 2022
Annual Meeting of Stockholders, filed with the SEC on April 25, 2022. Other
information regarding the interests of such individuals, who may be deemed to be
participants in the solicitation of proxies for the stockholders of Yumanity, is
set forth in the Proxy Statement and will be set forth in any other relevant
documents to be filed with the SEC. You may obtain free copies of these
documents as described above.
Cautionary Statement Regarding Forward-Looking Statements
This Current Report on Form 8-K and the exhibit furnished herewith contain
forward-looking statements, including statements made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act of 1995. These
statements may be identified by words and phrases such as "aims," "anticipates,"
"believes," "could," "designed to," "estimates," "expects," "forecasts," "goal,"
"intends," "may," "plans," "possible," "potential," "seeks," "will," and
variations of these words and phrases or similar expressions that are intended
to identify forward-looking statements. These forward-looking statements
include, without limitation, statements regarding the proposed merger between
Yumanity and Kineta and the proposed asset sale to Janssen, including whether
and when the transactions will be consummated; statements about the structure,
timing and completion of the proposed transactions; the listing of the combined
company on Nasdaq after the closing of the proposed merger; expectations
regarding the ownership structure of the combined company after the closing of
the proposed merger; the expected executive officers and directors of the
combined company; the expected cash position of each of Yumanity and Kineta and
the combined company at the closing of the proposed merger; the future
operations of the combined company; the nature, strategy and focus of the
combined company; the development and commercial potential and potential
benefits of any product candidates of the combined company; the executive and
board structure of the combined company; the location of the combined company's
corporate headquarters; anticipated preclinical and clinical drug development
activities and related timelines, including the expected timing for data and
other clinical and preclinical results; Kineta having sufficient resources to
advance its pipeline; and other statements that are not historical fact. Actual
results and the timing of events could differ materially from those anticipated
in such forward-looking statements as a result of these risks and uncertainties,
which include, without limitation: (i) the risk that the conditions to the
closing of the proposed transactions are not satisfied, including the failure to
timely obtain stockholder approval for the transactions, if at all;
(ii) uncertainties as to the timing of the consummation of the proposed
transactions and the ability of each of Yumanity, Kineta and Janssen to
consummate the proposed merger or asset sale, as applicable; (iii) risks related
to Yumanity's ability to manage its operating expenses and its expenses
associated with the proposed transactions pending closing; (iv) risks related to
the failure or delay in obtaining required approvals from any governmental or
quasi-governmental entity necessary to consummate the proposed transactions;
(v) the risk that as a result of adjustments to the exchange ratio, Yumanity
stockholders and Kineta shareholders could own more or less of the combined
company than is currently anticipated; (vi) risks related to the market price of
Yumanity's common stock relative to the exchange ratio; (vii) unexpected costs,
charges or expenses resulting from either or both of the proposed transactions;
(viii) potential adverse reactions or changes to business relationships
resulting from the announcement or completion of the proposed transactions;
(ix) the risk that the amount of the dividend distributed to Yumanity
stockholders in connection with the asset sale, if any, may be lower than
currently anticipated; (x) risks related to the inability of the combined
company to obtain sufficient additional capital to continue to advance these
product candidates and its preclinical programs; (xi) uncertainties in
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obtaining successful clinical results for product candidates and unexpected
costs that may result therefrom; (xii) risks related to the failure to realize
any value from product candidates and preclinical programs being developed and
anticipated to be developed in light of inherent risks and difficulties involved
in successfully bringing product candidates to market; and (xiii) risks
associated with the possible failure to realize certain anticipated benefits of
the proposed transactions, including with respect to future financial and
operating results. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking statements as a result
of these risks and uncertainties. These and other risks and uncertainties are
more fully described in periodic filings with the SEC, including the factors
described in the section titled "Risk Factors" in Yumanity's most recent Annual
or Quarterly Report filed with the SEC, and in other filings that Yumanity makes
and will make with the SEC in connection with the proposed transactions,
including the Proxy Statement. You should not place undue reliance on these
forward-looking statements, which are made only as of the date hereof or as of
the dates indicated in the forward-looking statements. Except as required by
law, Yumanity expressly disclaims any obligation or undertaking to update or
revise any forward-looking statements contained herein to reflect any change in
its expectations with regard thereto or any change in events, conditions or
circumstances on which any such statements are based.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
99.1 Press release, dated November 15, 2022.
104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
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