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Celcuity Inc. Announces $50 Million Private Placement Minneapolis, MN

Key Takeaway: Celcuity Inc. has announced a private placement expected to yield approximately $50 million in gross proceeds. Institutional investors will purchase pre-funded warrants for shares of common stock at a price of $8.70 per share. The proceeds from this placement will be utilized primarily to further develop gedatolisib, the company's lead therapeutic candidate, while the closing of the placement is anticipated to occur by October 20, 2023, pending customary conditions. Celcuity is also planning to enroll patients in additional clinical trials starting in early 2024.

Market Sentiment Analysis

POSITIVE FACTORS

  • Celcuity secures $50 million in gross proceeds from the private placement.
  • The funding will help advance the clinical development of gedatolisib.
  • The company's lead therapy has unique properties differentiating it from competitors.
  • Plans to initiate additional clinical trials indicate ongoing growth and development.

CONCERNS & RISKS

  • The private placement's closing is subject to customary conditions, introducing uncertainty.
  • Securities sold may not be offered or resold without proper registration, limiting liquidity.
  • Forward-looking statements carry inherent risks that could affect company performance.

Full Press Release Details

Celcuity Inc. Announces
$50 Million Private Placement
Minneapolis, MN, October
18, 2023 - Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for
oncology, announced today that it has entered into a securities purchase agreement to sell securities in a private placement that is expected
to result in gross proceeds of approximately $50 million. In the private placement, an institutional investor has agreed to purchase pre-funded
warrants to purchase shares of Celcuity's common stock at a price of $8.699 per warrant, each with an exercise price of $0.001 per
share (for aggregate consideration equating to $8.70 per share). Subject to certain limitations, each pre-funded warrant will be exercisable
immediately. The closing of the private placement is subject to customary closing conditions and is expected to occur on October 20, 2023.
The Company expects to use the net proceeds to advance clinical development of gedatolisib and for general corporate purposes.
The securities to be sold
in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or
any state or other jurisdiction's securities laws, and accordingly may not be offered or resold in the United States except pursuant
to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable
state securities laws. The Company has agreed to file a registration statement with the SEC registering the resale of the shares of common
stock issuable upon the exercise of the pre-funded warrants purchased in the private placement.
This press release shall
not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the
securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration
or qualification under the securities laws of any such state or other jurisdiction. Any offering of the securities under the resale registration
statement will only be made by means of a prospectus.
Celcuity is a clinical-stage biotechnology
company pursuing development of targeted therapies for oncology. The company's lead therapeutic candidate is gedatolisib, a potent,
pan-PI3K and mTOR inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved
and investigational therapies that target PI3K or mTOR alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib
in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer is currently enrolling
patients. More detailed information about the VIKTORIA-1 study can be found at ClinicalTrials.gov.
A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration
resistant prostate cancer, is planned to begin enrolling patients in the first quarter of 2024. The company's CELsignia companion
diagnostic platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit
from already approved targeted therapies. Celcuity is headquartered in Minneapolis.
Cautionary Note Regarding
Forward-Looking Statements
Any statements in this press
release about the Company's future expectations, plans and prospects, as well as any other statements regarding matters that are
not historical facts, may constitute "forward-looking statements" within the meaning of the Private Securities Litigation
Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed
or implied by such forward-looking statements. Such statements include, but are not limited to, statements about the expected closing
of the private placement, the anticipated use of proceeds from the private placement, the expected timing of clinical study related activities,
including without limitation, enrollment of patients and reporting of results, and other statements containing the words "believes,"
"anticipates," "plans," "expects," and similar expressions. You should not place undue reliance on
forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible
to predict and, in some cases, beyond the Company's control. Risks that contribute to the uncertain nature of the forward-looking
statements include, but are not limited to, whether the conditions for the closing of the private placement will be satisfied; the Company's
limited operating history; the Company's potential inability to develop and commercialize gedatolisib; challenges the Company may
face in developing and maintaining relationships with pharmaceutical company partners; the complexity and timeline for development of
the Company's CELsignia tests and gedatolisib; the uncertainties and costs associated with clinical trials; the uncertainty regarding
market acceptance of the Company's products and services by physicians, patients, third-party payors and others in the medical community,
and with the size of market opportunities available to the Company; the pricing of drug products and molecular and other diagnostic products
and services that compete or may compete with the Company; uncertainty with insurance coverage and reimbursement for the Company's
products and services; difficulties the Company may face in managing growth, such as hiring and retaining a qualified sales force and
attracting and retaining key personnel; changes in government regulations; and obtaining and maintaining intellectual property protection
for the Company's technology and time and expense associated with defending third-party claims of intellectual property infringement,
investigations or litigation threatened or initiated against the Company. Forward-looking statements are subject to numerous risks, uncertainties,
and conditions, many of which are beyond the control of Celcuity. These include, but are not limited to, delays, disruptions or adverse
results in our clinical trials and those risks set forth in the Risk Factors section in Celcuity's Annual Report on Form 10-K for
the year ended December 31, 2022, filed with the Securities and Exchange Commission on March 23, 2023, and our subsequent Quarterly Reports
on Form 10-Q. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.
Celcuity undertakes no obligation to update these statements for revisions or changes after the date of this press release, except as
SOURCE: Celcuity Inc.

Frequently Asked Questions

What is the amount raised in Celcuity's private placement?

Celcuity has announced a private placement expected to raise approximately $50 million.

What is the lead therapeutic candidate of Celcuity?

Celcuity's leading therapeutic candidate is gedatolisib, a potent pan-PI3K and mTOR inhibitor.

When is the VIKTORIA-1 clinical trial enrolling patients?

The VIKTORIA-1 clinical trial is currently enrolling patients for advanced breast cancer.

What is the purpose of the CELsignia diagnostic platform?

The CELsignia platform analyzes live patient tumor cells to identify cancer patients for targeted therapies.

When will the closing of the private placement occur?

The closing of the private placement is expected to occur on October 20, 2023.

Last updated: Oct 18, 2023