On February 13, 2025 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing the tuspetinib (TUS)-based triple drug frontline therapy to treat patients with newly diagnosed AML, reported it has entered into a common share purchase agreement and registration rights agreement with an institutional investor (Press release, Aptose Biosciences, FEB 13, 2025, View Source [SID1234650266]).

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The Committed Equity Facility agreement provides Aptose the right, in its sole option and discretion without obligation, to sell and issue up to $25 million of its common shares (the "Common Shares") over the course of 24 months to the Investor, subject to certain conditions being met, and subject to certain limitations and conditions imposed by the Nasdaq Capital Market ("Nasdaq"), the U.S. Securities and Exchange Commission (the "SEC") and other regulators. The securities offered have not been registered under the Securities Act of 1933 and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. No Common Shares will be sold on the Toronto Stock Exchange ("TSX") or other trading market in Canada under the common share purchase agreement. The TSX has conditionally approved the committed equity facility based on the exemption set forth in Section 602.1 of the TSX Company Manual.

Aptose also announced it has entered into a sales agreement to issue and sell Common Shares through "at-the-market" (ATM) distributions on the Nasdaq. Aptose will decide the timing, price, and number of shares sold. Prospectus supplements (the "Prospectus Supplements") have been filed with the SEC qualifying the offer and sale of Common Shares (i) to the Investor with an aggregate offering price of up to US $25 million and (ii) pursuant to the sales agreement with an aggregate offering price of up to US $1 million. The Prospectus Supplements and accompanying prospectus are available on EDGAR at www.sec.gov and can also be accessed on the SEC’s website at View Source Investors should review the Prospectus Supplements and other filed documents for comprehensive information about the issuer and the offering before making any investments.

This press release does not constitute an offer to sell or the solicitation of offers to buy any securities of Aptose, and shall not constitute an offer, solicitation, or sale of any security in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 12, 2025 Aligos Therapeutics, Inc. (Nasdaq: ALGS, "Aligos", "Company"), a clinical stage biotechnology company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, reported that it has entered into a securities purchase agreement for a private placement that is expected to result in gross proceeds of approximately $105 million, before deducting placement agents’ fees and other expenses (Press release, Aligos Therapeutics, FEB 12, 2025, View Source [SID1234650202]).

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The private placement is being led by a life sciences dedicated investment firm with participation from other new and existing institutional investors.

Aligos currently expects to use the net proceeds from the private placement, together with its existing cash, cash equivalents and investments, to fund the continued advancement of ALG-000184 into a Phase 2 clinical study in subjects with chronic hepatitis B virus infection (CHB) and for other general corporate purposes.

Aligos believes its cash, cash equivalents and investments, including the expected net proceeds from the private placement, will provide sufficient funding of planned operations into the second half of 2026.

In the private placement, Aligos is selling 2,103,307 shares of common stock, consisting of 1,427,000 shares of voting common stock and 676,307 shares of non-voting common stock, pre-funded warrants to purchase up to 1,922,511 shares of voting common stock, and accompanying warrants to purchase up to 2,012,909 shares of voting common stock at a combined price per share of common stock and accompanying warrant of $26.0825 and a combined price per pre-funded warrant and accompanying warrant of $26.0824. Each pre-funded warrant will have a nominal exercise price of $0.0001 per share of voting common stock, will be immediately exercisable and will be exercisable until exercised in full. The accompanying warrants will have an exercise price of $26.02 per share of common stock, will be immediately exercisable and will expire on February 13, 2032. The private placement is expected to close on February 13, 2025 subject to the satisfaction of customary closing conditions.

Jefferies and Piper Sandler are acting as placement agents for the private placement. H.C. Wainwright & Co. is acting as financial advisor in connection with the transaction.

The securities sold in this private placement have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Aligos granted registration rights to the purchasers in private placements, and has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock issued in the private placement, the shares of common stock issuable upon exercise of the pre-funded warrants issued in the private placement and the shares of common stock issuable upon exercise of the accompanying warrants issued in the private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or 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 jurisdiction.

On February 12, 2025 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, and Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, reported the initial phase of a program to improve provider access to GRAIL’s Galleri multi-cancer early detection (MCED) test (Press release, Grail, FEB 12, 2025, View Source [SID1234650223]). Providers can now order the Galleri test directly from GRAIL through the Quest Diagnostics connectivity system. The Quest Diagnostics connectivity system enables providers in the United States to order and receive reports of laboratory tests electronically through Quest’s Quanum laboratory portal and more than 900 electronic health record (EHR) systems. More than 500,000 providers used the Quest connectivity system last year.

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The integration will help streamline the process of ordering the Galleri test for physicians. It will also increase availability by allowing patients access to the test at any of Quest’s approximately 7,400 patient access points nationwide. Patients with a test order from their physician can now go directly to Quest without needing to bring a Galleri test kit to the blood draw appointment.

"Quest Diagnostics and GRAIL share a commitment to improving access to cancer screening and have worked productively together to enable patient access to GRAIL’s Galleri test via Quest’s phlebotomy network since 2021," said Mark Gardner, Senior Vice President, Molecular Genomics and Oncology for Quest Diagnostics. "Integrating GRAIL’s Galleri test into the Quest connectivity system is the next step in this collaboration. We expect it to increase patient access by giving Quest’s provider clients the ability to seamlessly order the test through Quest, same as they do for other blood work. This collaboration brings to life the tremendous value of Quest’s ability to scale diagnostic innovation to make it accessible for all."

Cancers growing in the body shed DNA into the bloodstream. These DNA fragments act like a unique "fingerprint" of cancer. With a single blood draw, the Galleri test screens for the "fingerprint" of many of the deadliest cancers before they become symptomatic, including those with no recommended screening tests today. It can also provide doctors with information on the cancer’s origin to help predict the tissue type or organ associated with the cancer signal. The Galleri test is prescription only, recommended for adults with an elevated risk for cancer, such as those age 50 or older, and is to be used in addition to recommended cancer screenings.

"We know every minute counts for busy providers, their staff and their patients, which is why we’re so pleased to work with Quest to offer a seamless experience that fits into providers’ existing ordering process," said Josh Ofman, MD, MSHS, President at GRAIL. "While today there are recommended screenings for five cancers, nearly 70% of deaths are caused by cancers with no recommended screening test. We believe this integration will help to make it easier to incorporate the Galleri test into routine exams to help screen for cancer before it becomes symptomatic when outcomes may be improved."

On February 12, 2025 Alkermes plc (Nasdaq: ALKS) reported financial results for the quarter and year ended Dec. 31, 2024 and provided financial expectations for 2025 (Press release, Alkermes, FEB 12, 2025, View Source [SID1234650203]).

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"2024 marked the completion of a multi-year effort to transition the business into a highly profitable, pure-play neuroscience company. We enter 2025 with a diversified portfolio of proprietary commercial products generating substantial profitability and an advancing development pipeline that represents a significant value creation opportunity in one of the most exciting potential new therapeutic categories in neuroscience," said Richard Pops, Chief Executive Officer of Alkermes. "Looking ahead, we are well positioned to deliver on our financial goals and advance the development programs for our portfolio of orexin 2 receptor agonists. This year, we have clear objectives for our pipeline as we complete the phase 2 studies for ALKS 2680 in narcolepsy, with data expected in the second half of the year, and prepare to initiate the ALKS 2680 phase 2 study in idiopathic hypersomnia and advance ALKS 4510 and ALKS 7290 into planned phase 1 studies in disease areas beyond central disorders of hypersomnolence. Each of these initiatives is an important element of our strategy to unlock what we believe is a multi-billion-dollar market opportunity for this category."

"2024 was Alkermes’ strongest year of financial and operational performance to date. Financially, we generated more than $1 billion in revenue from our proprietary commercial product portfolio, delivered EBITDA from continuing operations of approximately $452 million, repurchased $200 million of the company’s ordinary shares, retired approximately $290 million of debt and ended the year debt-free with approximately $825 million of cash and investments on the balance sheet. Operationally, we completed the sale of our manufacturing business in Ireland and made significant progress advancing our neuroscience development pipeline," said Blair Jackson, Chief Operating Officer of Alkermes. "We will continue to manage the business with a sharp focus on efficiency and profitability as we invest in the programs that we believe will drive the company’s next phase of growth."

Key Financial Highlights

Revenues

(In millions)

Three Months Ended
December 31,

Twelve Months Ended
December 31,

2024

2023

2024

2023

Total Revenues

$

430.0

$

377.5

$

1,557.6

$

1,663.4*

Total Proprietary Net Sales

$

307.7

$

242.0

$

1,083.5

$

920.0

VIVITROL

$

134.1

$

102.4

$

457.3

$

400.4

ARISTADAi

$

96.6

$

83.4

$

346.2

$

327.7

LYBALVI

$

77.0

$

56.2

$

280.0

$

191.9

Profitability

(In millions)

Three Months Ended
December 31,

Twelve Months Ended
December 31,

2024

2023

2024

2023*

GAAP Net Income From Continuing Operations

$

145.7

$

160.6

$

372.1

$

519.2

GAAP Net Income (Loss) From Discontinued Operations

$

0.8

$

(47.8)

$

(5.1)

$

(163.4)

GAAP Net Income

$

146.5

$

112.8

$

367.1

$

355.8

Non-GAAP Net Income From Continuing Operations

$

173.4

$

81.8

$

494.4

$

396.5

Non-GAAP Net Income (Loss) From Discontinued Operations

$

0.8

$

(44.4)

$

(5.1)

$

(152.9)

Non-GAAP Net Income

$

174.2

$

37.4

$

489.3

$

243.7

EBITDA From Continuing Operations

$

170.0

$

72.8

$

452.4

$

486.3

EBITDA From Discontinued Operations

$

1.1

$

(40.5)

$

(5.8)

$

(162.5)

EBITDA

$

171.1

$

32.3

$

446.6

$

323.8

*As a result of the successful resolution of the arbitration with Janssen Pharmaceutica N.V., the twelve months ended December 31, 2023 included approximately $195.4 million of back royalties (and related interest) related to U.S. net sales of long-acting INVEGA products that would ordinarily have been recognized in prior periods.

Revenue Highlights

LYBALVI

Revenues for the fourth quarter were $77.0 million.
Fourth quarter revenues and total prescriptions grew 37% and 30%, respectively, compared to the fourth quarter of 2023.
During the quarter, the company recorded LYBALVI revenue of approximately $4 million related to year-end inventory fluctuations.
ARISTADAi

Revenues for the fourth quarter were $96.6 million.
Fourth quarter revenues grew 16% compared to the fourth quarter of 2023.
During the quarter, the company recorded ARISTADA revenue of approximately $9 million related to year-end inventory fluctuations and gross-to-net favorability, primarily driven by Medicaid utilization adjustments.
VIVITROL

Revenues for the fourth quarter were $134.1 million.
Fourth quarter revenues grew 31% compared to the fourth quarter of 2023.
During the quarter, the company recorded VIVITROL revenue of approximately $23 million related to year-end inventory fluctuations and gross-to-net favorability, primarily driven by Medicaid utilization adjustments.
Manufacturing & Royalty Revenues

Royalty revenues from XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI for the fourth quarter were $36.5 million.
VUMERITY manufacturing and royalty revenues for the fourth quarter were $35.0 million.
FAMPYRA manufacturing and royalty revenues for the fourth quarter were $22.9 million. The company does not expect to record any FAMPYRA revenue going forward.
RISPERDAL CONSTA manufacturing revenues for the fourth quarter were $14.7 million.
Key Operating Expenses

Please see Note 1 below for details regarding discontinued operations.

(In millions)

Three Months Ended
December 31,

Twelve Months Ended
December 31,

2024

2023

2024

2023

R&D Expense – Continuing Operations

$

58.2

$

73.9

$

245.3

$

270.8

R&D Expense – Discontinued Operations

$

(1.1)

$

21.5

$

5.8

$

116.2

SG&A Expense – Continuing Operations

$

147.0

$

169.8

$

645.2

$

689.8

SG&A Expense – Discontinued Operations

$

–

$

19.4

$

–

$

48.6

Balance Sheet

At Dec. 31, 2024, the company recorded cash, cash equivalents and total investments of $824.8 million, compared to $813.4 million at Dec. 31, 2023.
In December 2024, the company prepaid and retired in full all of its outstanding long-term debt in the amount of approximately $290 million.
Financial Expectations for 2025

All line items are according to GAAP, except as otherwise noted.

In millions

2025 Expectations

Total Revenues

$1,340 – $1,430

VIVITROL Net Sales

$440 – $460

ARISTADAi Net Sales

$335 – $355

LYBALVI Net Sales

$320 – $340

Cost of Goods Sold

$185 – $205

R&D Expenses

$305 – $335

SG&A Expenses

$655 – $685

GAAP Net Income a

$175 – $205

EBITDA

$215 – $245

Adjusted EBITDA

$310 – $340

Effective Tax Rate

~17%

a Expected 2025 weighted average basic share count of approximately 165.5 million shares outstanding and a weighted average diluted share count of approximately 169.5 million shares outstanding.

Notes and Explanations

1. The company determined that upon the separation of its former oncology business, completed on Nov. 15, 2023, the oncology business met the criteria for discontinued operations in accordance with Financial Accounting Standards Board Accounting Standards Codification 205, Discontinued Operations. Accordingly, the accompanying selected financial information has been updated to present the results of the oncology business as discontinued operations for the three and twelve months ended Dec. 31, 2023.

Conference Call
Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. EST (1:00 p.m. GMT) on Wednesday, Feb. 12, 2025, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes’ website.

On February 12, 2025 OnCusp Therapeutics, Inc., a clinical stage biopharmaceutical company dedicated to transforming cutting-edge preclinical innovation into clinically validated treatments for cancer patients, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to CUSP06, a Cadherin-6 targeting Antibody-Drug Conjugate (CDH6 ADC) and the company’s lead program, for the treatment of patients with platinum-resistant ovarian cancer (PROC) (Press release, OnCusp Therapeutics, FEB 12, 2025, View Source [SID1234650224]).

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"We are extremely pleased that the FDA granted Fast Track Designation to CUSP06," said Eric Slosberg, PhD, Chief Development Officer of OnCusp Therapeutics. "The early results from our Phase 1 trial have been encouraging, and this designation will expedite our efforts to bring this potentially transformative therapy to patients. Given the need for new therapeutic options in this underserved population, we are committed to working closely with the FDA to accelerate its development."

The ongoing Phase 1 multicenter study is evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of CUSP06 in adults with platinum-refractory/resistant ovarian cancer and other advanced solid tumors (CUSP06-1001). Early data from the trial have shown promising anti-tumor activity and a manageable safety profile, supporting further development of the program.

About CUSP06

CUSP06, a CDH6 ADC, is composed of a proprietary antibody with high CDH6 binding affinity, a protease-cleavable linker, and an exatecan payload (a potent and clinically validated topoisomerase-1 inhibitor). The linker is designed to complement the exatecan payload, enabling a stable and homogenous ADC. The payload is a weak substrate for BCRP/P-gp, which are drug efflux pumps that drive chemoresistance to many therapies. In preclinical data, this linker-payload has been shown to have an increased "bystander effect" compared to competitor ADCs. CUSP06 has a drug-to-antibody ratio of eight. OnCusp obtained the exclusive global rights (outside of China) to lead the development and commercialization of CUSP06 from Multitude Therapeutics in 2022. CUSP06 is being evaluated in a Phase 1 study in patients with platinum-refractory/resistant ovarian cancer and other advanced solid tumors. Additional information on the CUSP06-1001 (NCT06234423) trial can be found at clinicaltrials.gov.

About Platinum-Resistant Ovarian Cancer

Ovarian cancer is the leading cause of death from gynecologic malignancies in the United States, with approximately 20,000 new cases diagnosed annually.[1] Platinum-based chemotherapy is a standard first-line treatment, but approximately 80% of patients who respond to initial treatment will develop platinum resistance, typically within two years.[2] Platinum-resistant ovarian cancer is defined as disease progression within six months of completing platinum-based therapy and carries a particularly poor prognosis, with median survival of only 9-12 months and limited effective treatment options.[2] Despite recent therapeutic advances, the 5-year survival rate for patients with platinum-resistant disease remains around 15%, highlighting a critical unmet need for new therapeutic approaches.[1],[3]

About Fast Track Designation

Fast Track Designation is intended to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. Programs with FTD may benefit from more frequent meetings with the FDA, eligibility for Accelerated Approval and Priority Review if relevant criteria are met, and the potential for a rolling review of the Biologics License Application (BLA).