Yumanity Therapeutics Reports Third Quarter 2022 Financial Results and Recent Corporate Developments
2022年11月14日 - 10:16PM
Yumanity Therapeutics, Inc. (“Yumanity” or the “Company”) (Nasdaq:
YMTX), a clinical-stage biopharmaceutical company, today announced
financial results for the third quarter ended September 30, 2022
and provided an overview of the Company’s recent corporate
developments.
Recent Corporate Developments
- On November 10, 2022, Yumanity announced the effectiveness of a
registration statement on Form S-4 (the “Registration Statement”)
with the U.S. Securities and Exchange Commission (the
“SEC”) in connection with Yumanity’s previously announced proposed
sale of Yumanity’s lead clinical-stage product candidate, YTX-7739,
as well as Yumanity’s unpartnered discovery-stage neuroscience
product candidates and targets to Janssen Pharmaceutica
NV (“Janssen”) for $26 million in cash as well as Yumanity’s
proposed merger with Kineta, Inc. (“Kineta”) under which
Kineta will become a wholly-owned subsidiary of Yumanity in an
all-stock transaction, resulting in a combined publicly traded
company re-named Kineta, Inc. Yumanity subsequently filed a
definitive proxy statement and prospectus (the “Proxy Statement”)
which provides important information about Yumanity and the
proposed transactions, both of which were announced on June 6,
2022. Yumanity is mailing the Proxy Statement to stockholders of
record as of the close of business on November 4, 2022. The Proxy
Statement will be accompanied by a voting instruction form or a
proxy card relating to the special meeting of Yumanity's
stockholders to approve the asset sale and merger (the “Special
Meeting”) which will be held in a virtual-only format via live
audio webcast at 10:00 a.m., Eastern Time, on December 13, 2022, at
www.virtualshareholdermeeting.com/YMTX2022SM, unless postponed or
adjourned to a later date.
Third Quarter 2022 Financial Highlights
- Cash position: As of September 30, 2022, cash,
cash equivalents and investments were $8.4 million, compared to
$36.5 million as of December 31, 2021. The decrease was primarily
due to a $12.8 million payment to extinguish the Company’s
remaining debt during the first quarter of 2022, spending on the
clinical development of YTX-7739 primarily in the first quarter of
2022, and costs related to being a public company. As of the
issuance date of the condensed consolidated financial statements
for the period ended September 30, 2022, the Company expects that,
absent either strategic transaction, its cash, cash equivalents and
marketable securities will be sufficient to fund its operating
expenses early into the first quarter of 2023.
- Research and development (R&D) expense:
Research and development expense was $0.7 million compared to $6.6
million for the third quarter of 2021. The decrease in R&D
expense was primarily due to the elimination of a significant
portion of the Company’s R&D personnel in connection with the
restructuring announced in February 2022 as well as pausing of
clinical development efforts for YTX-7739 while the U.S. Food and
Drug Administration partial clinical hold is in effect.
- General and administrative expense: General
and administrative expense was $4.2 million compared to $4.5
million for the third quarter of 2021. The decrease was primarily
attributable to lower personnel costs resulting from the
restructuring announced in February 2022, offset by higher legal
fees and investment banking fees incurred in connection with the
transactions contemplated by the merger agreement with Kineta and
the asset purchase agreement with Janssen.
- Net loss: The Company reported a net loss of
$3.4 million, or $0.31 per basic and diluted share, compared to a
net loss of $10.0 million, or $0.97 per basic and diluted share for
the third quarter of 2021. The decrease in net loss was due
primarily to the decrease in R&D expense as described above.
The Company expects to continue to generate operating losses for
the foreseeable future, although at reduced expected levels as a
result of restructuring actions taken in the nine months ended
September 30, 2022.
|
YUMANITY THERAPEUTICS, INC.CONDENSED
CONSOLIDATED STATEMENT OF OPERATIONS
(unaudited)(in thousands, except share/unit
amounts) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Collaboration revenue |
$ |
1,402 |
|
|
$ |
1,635 |
|
|
$ |
4,081 |
|
|
$ |
7,282 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
726 |
|
|
|
6,624 |
|
|
|
6,764 |
|
|
|
20,729 |
|
General and administrative |
|
4,180 |
|
|
|
4,513 |
|
|
|
14,562 |
|
|
|
15,277 |
|
Total operating expenses |
|
- |
|
|
|
- |
|
|
|
3,903 |
|
|
|
- |
|
|
|
4,906 |
|
|
|
11,137 |
|
|
|
25,229 |
|
|
|
36,006 |
|
Loss from operations |
|
(3,504 |
) |
|
|
(9,502 |
) |
|
|
(21,148 |
) |
|
|
(28,724 |
) |
Other income (expense), net |
|
141 |
|
|
|
(454 |
) |
|
|
(441 |
) |
|
|
(368 |
) |
Net loss |
$ |
(3,363 |
) |
|
$ |
(9,956 |
) |
|
|
(21,589 |
) |
|
|
(29,092 |
) |
|
|
|
|
|
|
|
|
Net loss per share/unit, basic and diluted |
$ |
(0.31 |
) |
|
$ |
(0.97 |
) |
|
$ |
(2.00 |
) |
|
$ |
(2.84 |
) |
|
|
|
|
|
|
|
|
Weighted average common shares/units outstanding, basic and
diluted |
|
10,855,751 |
|
|
|
10,304,775 |
|
|
|
10,817,830 |
|
|
|
10,239,502 |
|
|
|
|
|
|
|
|
|
SELECTED CONSOLIDATED BALANCE SHEET DATA
(unaudited)(in thousands) |
|
|
September 30, |
December 31, |
|
2022 |
|
2021 |
Cash, cash equivalents and investments |
$ |
8,416 |
|
$ |
36,501 |
Total current assets |
|
9,080 |
|
|
42,708 |
Working capital |
|
4,977 |
|
|
20,045 |
Total assets |
|
9,579 |
|
|
62,932 |
Total debt |
|
- |
|
|
13,162 |
Total stockholders' equity |
|
5,476 |
|
|
23,497 |
|
|
|
|
|
|
About Yumanity Yumanity is a clinical-stage
biopharmaceutical company dedicated to accelerating the revolution
in the treatment of neurodegenerative diseases through its
scientific foundation and drug discovery platform. Yumanity’s drug
discovery platform enables the Company to rapidly screen for
potential disease-modifying therapies by overcoming the toxicity of
misfolded proteins associated with neurogenerative diseases.
Yumanity’s pipeline consists of programs focused on Parkinson’s
disease, Lewy body dementia, multi-system atrophy, amyotrophic
lateral sclerosis (ALS or Lou Gehrig’s disease) and frontotemporal
lobar dementia (FTLD). For more information, please visit
www.yumanity.com.
Additional Information and Where to Find It
This press release 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
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 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 press release
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 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 press release 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 of 1933, as
amended.
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 Statements Regarding Forward-Looking
StatementsThis press release contains 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; Yumanity’s cash runway; 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
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.
Investors:Burns McClellan, Inc.Lee Roth(212)
213-0006 ext. 331
Media:Burns McClellan, Inc.Robert Flamm,
Ph.D.rflamm@burnsmc.com
Source: Yumanity Therapeutics, Inc.
Yumanity Therapeutics (NASDAQ:YMTX)
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