NuCana Prices $7 Million Registered Direct Offering

On May 6, 2025 NuCana plc (NASDAQ: NCNA), a clinical-stage biopharmaceutical company that focuses on significantly improving treatment outcomes for patients with cancer, reported that it has priced a registered direct offering consisting of 10,845,985 American Depository Shares, or ADSs, (or pre-funded warrants in lieu thereof) with each ADS (or pre-funded warrant) accompanied by (i) a Series A warrant to purchase one (1) ADS at an initial exercise price of $0.8068 per share and (ii) a Series B Warrant to purchase one (1) ADS at an initial exercise price of $1.61 per share (Press release, Nucana, MAY 6, 2025, View Source [SID1234652585]). The combined public offering price of each ADS together with the accompanying Series A and Series B Warrants is $0.6454, and the combined offering price of each pre-funded warrant together with the accompanying Series A and Series B warrants is $0.6454, minus the United States dollar equivalent of £0.01, based on the exchange rate on the date of pricing. The gross proceeds of the offering are expected to be approximately $7 million before deducting placement agent fees and offering expenses and are expected to be used to fund activities relating to the advancement of our drug discovery and development programs, and for other general corporate purposes, including, but not limited to, working capital, capital expenditures, investments, acquisitions, should we choose to pursue any, and collaborations. The closing of the offering is expected to occur on or about May 7, 2025, subject to the satisfaction of customary closing conditions.

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Laidlaw & Company (UK) Ltd. is acting as the sole placement agent for the offering.

This registered offering is being made by the Company pursuant to a registration statement on Form F-1 (File No. 333-286716), which was declared effective by the United States Securities and Exchange Commission ("SEC") on May 5, 2025. The securities may only be offered by means of a prospectus. Copies of the prospectus may be obtained, when available, at the SEC’s website at www.sec.gov or from Laidlaw & Company (UK) Ltd., 521 5th Avenue, 12th Floor, New York, NY 10175, or by telephone at (212) 953-4900, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities 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.

Neurocrine Biosciences to Present at Upcoming Investor Conferences in May

On May 6, 2025 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will participate at two upcoming investor conferences in May (Press release, Neurocrine Biosciences, MAY 6, 2025, View Source [SID1234652584]).

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Chief Executive Officer Kyle Gano and Vice-President of Investor Relations Todd Tushla will present at the BofA Securities 2025 Health Care Conference on Tuesday, May 13, 2025 at 11:20 AM Pacific Time in Las Vegas.
Chief Financial Officer Matt Abernethy and Chief Commercial Officer Eric Benevich will present at the RBCCM Global Healthcare Conference on Tuesday, May 20, 2025 at 11:30 AM Eastern Time in New York.

The live webcasts can be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcasts will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

Myriad Genetics Reports First Quarter 2025 Financial Results; Updates 2025 Financial Guidance

On May 6, 2025 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, reported financial results for its first quarter ended March 31, 2025 and updated its previously issued financial guidance on business performance for the full-year 2025 (Press release, Myriad Genetics, MAY 6, 2025, View Source [SID1234652583]).

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"We had a challenging first quarter of 2025 with strength in our prenatal and oncology MyRisk tests offset by softness in GeneSight and unaffected hereditary cancer tests. While we are actively working on initiatives to re-accelerate testing volumes, this will take time; therefore we are lowering our 2025 financial guidance. We are taking immediate steps to reduce overall expenditures while prioritizing investment in new product development and programs intended to drive revenue growth," said Sam Raha, President and CEO, of Myriad Genetics.

"As a new leadership team we are focused on unlocking Myriad Genetics’ potential by implementing a compelling strategy, strengthening our organizational capabilities, and improving execution."

Financial and Operational Highlights
•Test volumes of 385,000 in the first quarter of 2025 increased 1% year-over-year.
•The following table summarizes year-over-year testing volume changes in the company’s core product categories:
Three Months Ended March 31,
(in thousands) 2025 2024 % Change
Product volumes:
Hereditary cancer
73 71 3 %
Tumor profiling(1)
12 14 (14) %
Prenatal 173 172 1 %
Pharmacogenomics
127 124 2 %
Total 385 381 1 %
(1) Tumor Profiling decreased for the three months ended March 31, 2025 compared to the same period in the prior year due primarily to a decrease in testing volume for EndoPredict due to the sale of the company’s international EndoPredict business in August 2024.

•The following table summarizes year-over-year revenue changes in the company’s core product categories:
Three Months Ended March 31,
(in millions)
2025 2024 % Change
Product revenues:
Hereditary cancer
$ 86.3 $ 88.1 (2) %
Tumor profiling(1)
29.3 30.9 (5) %
Prenatal 49.3 44.3 11 %
Pharmacogenomics
31.0 38.9 (20) %
Total $ 195.9 $ 202.2 (3) %
(1) Tumor Profiling decreased for the three months ended March 31, 2025 compared to the same period in the prior year due primarily to a decrease in testing volume for EndoPredict due to the sale of the company’s international EndoPredict business in August 2024.

•Operating expenses in the first quarter of 2025 were $163.2 million, decreasing $2.3 million year-over-year. Adjusted operating expenses in the first quarter of 2025 increased $1.5 million year-over-year to $140.6 million, reflecting the company’s commitment to disciplined cost management while maintaining investments in key strategic areas, such as research and development.
•Operating loss in the first quarter of 2025 was $29.0 million, an increase of $1.1 million year-over-year; adjusted operating loss in the first quarter of 2025 was $5.5 million.

Cash Flow and Liquidity
First quarter 2025 cash flow used in operations was $16.3 million; adjusted cash flow used in operations in the first quarter of 2025 was $10.4 million, a decrease of $1.1 million year-over-year. Capital expenditures and capitalization of internal use software costs were $8.3 million in the first quarter 2025.

As of the end of the first quarter 2025, the company had cash and cash equivalents of $92 million and the ability to access an incremental $42 million of availability under its asset-based credit facility (ABL Facility). The continued availability and amount thereof under the ABL Facility is subject to maintaining compliance with the fixed charge coverage ratio and maintaining $20 million of cash in a controlled account with the administrator of the ABL Facility.

Business Performance and Highlights
Oncology
The Oncology business delivered revenue of $77.7 million in the first quarter of 2025.
•First quarter 2025 hereditary cancer testing volume and revenue in Oncology grew 5% and 0% year-over-year, respectively, as MyRisk with RiskScore testing volume in the affected population grew 11% year-over-year. A year-over-year decrease in average revenue per hereditary cancer test in the first quarter 2025 was largely due to a difference in change in estimated revenue related to prior periods.
•First quarter 2025 Prolaris test revenue declined 2% year-over-year as Myriad Genetics continues to educate clinicians on how it believes the Prostate Cancer Guidelines from the National Comprehensive Cancer Network (NCCN) underscore the critical role of Myriad Genetics’ portfolio of offerings across the patient’s prostate cancer journey.
•New clinical data highlighting the performance of the Precise MRD test was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) conference in April 2025 and additional clinical data will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in May 2025.
•Myriad continues to make progress and intends to commercially launch its first AI-driven prostate cancer test, in partnership with PATHOMIQ, by end of 2025.

Women’s Health
The Women’s Health business delivered revenue of $87.2 million in the first quarter of 2025.
•Prenatal testing revenue in the first quarter of 2025 grew 11% year-over-year reflecting growth across both carrier screen and non-invasive prenatal testing. First quarter saw positive early adoption of the mid-fourth quarter 2024 launch of the Prequel Early Gestational Age test.
•First quarter 2025 hereditary cancer testing revenue for the unaffected population decreased 4% year-over-year on stable volume as the company continues to develop and deploy its electronic medical records (EMR) efforts and further expand its breast cancer risk assessment programs across its current and new provider base.

Pharmacogenomics
GeneSight test revenue was $31.0 million in the first quarter of 2025. As anticipated, first quarter this test revenue was impacted by UnitedHealthcare’s decision to discontinue coverage of multi-gene panel pharmacogenetic testing, effective in the first quarter of 2025, as well as Myriad Genetics’ actions to streamline the Pharmacogenomics organization.

Financial Guidance
Myriad Genetics does not provide forward-looking guidance in accordance with accounting principles generally accepted in the United States (GAAP) for the measures on which it provides forward-looking non-GAAP guidance as the company is unable to provide a quantitative reconciliation of forward-looking non-GAAP measures to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because of the inherent difficulty in accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such reconciliations that have not yet occurred, are dependent on various factors, are out of the company’s control, or cannot be reasonably predicted. Such adjustments include, but are not limited to, real estate optimization and transformation initiatives, certain litigation charges and loss contingencies, costs related to acquisitions/divestitures and the related amortization, impairment and related charges, depreciation, equity compensation, tax benefits, and other adjustments. For example, stock-based compensation may fluctuate based on the timing of employee stock transactions and unpredictable fluctuations in the company’s stock price. Any associated estimate of these items and its impact on GAAP performance could vary materially.

Below is a table updating Myriad Genetics’ full-year 2025 financial guidance*:
(in millions, except per share amounts) INITIAL 2025 Guidance
CURRENT 2025 Guidance
FY 2025 Comments
Revenue $840 – $860
$807 – $823
Lowered 2025 revenue range mid-point by $35 million reflecting an updated outlook for our pharmacogenomics business and hereditary cancer testing in our Women’s Health business.
Gross Margin %
69.5% – 70.5% 68.5% – 69.5% Gross margins expected to fluctuate in any quarter given product mix and pricing trends.
Adjusted Operating Expenses
$575 – $595
$555 – $565
Change reflects moderating planned expenditures for remainder of 2025.
Adjusted EBITDA** $25 – $35
$19 – $27
Adjusted EPS*** $0.07 – $0.11
$(0.02) – $0.02
*
Assumes currency rates as of May 6, 2025.
** Adjusted EBITDA is defined as Net Income (loss) plus income tax expense (benefit), total other income (expense), non-cash operating expenses, such as amortization of intangible assets, depreciation, impairment of long-lived assets, and share-based compensation expense, and one-time expenses such as expenses from real estate optimization initiatives, transformation initiatives, legal settlements, and divestitures and acquisitions.
***
Full-year 2025 adjusted EPS is based on a 94 million share count.

These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release.

Conference Call and Webcast
A conference call will be held today, Tuesday, May 6, 2025, at 4:30 p.m. ET to discuss Myriad Genetics’ financial results and business developments for the first quarter 2025. A live webcast of the conference call can be accessed on Myriad Genetics’ Investor Relations website at investor.myriad.com. To participate in the live conference call via telephone, please register at View Source Upon registering, a dial-in number and unique PIN will be provided to join the conference call. Following the conference call, an archived webcast of the call will be available at investor.myriad.com.

Moleculin Announces World Health Organization Approval of “naxtarubicin” as International Non-Proprietary Name for Annamycin

On May 6, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viral infections, reported that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization approved "naxtarubicin1" for the non-proprietary name of the Company’s next-generation anthracycline in development, Annamycin (Press release, Moleculin, MAY 6, 2025, View Source [SID1234652582]). Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases and the Company believes it may have the potential to treat additional indications.

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"The assignment of the non-proprietary name represents an important step in the development and potential future commercialization of Annamycin. The INN naming process meticulously evaluates proposed drug names for adherence to nomenclature guidelines and potential conflicts, followed by expert consensus and public review. With this INN now given and prior approval by the United States Adopted Names (USAN), we have the ability to establish a universally recognized and conflict-free nonproprietary drug name for Annamycin," said Walter Klemp, Chairman and CEO of Moleculin. "Looking ahead, our team remains focused on the successful execution of our ongoing pivotal, adaptive design Phase 3 MIRACLE trial of Annamycin for the treatment R/R AML and look forward to reporting initial data in the second half of 2025."

Commonly referred to as a generic name, each INN is a unique name used to identify pharmaceutical substances or active pharmaceutical ingredients. Each active substance that is to be marketed as a pharmaceutical must be granted a unique name of worldwide acceptability to ensure the clear identification, safe prescription and dispensing of medicines to patients. Nonproprietary names are intended for wide use ranging from labelling and product information to drug regulation and scientific literature. Moleculin expects to transition to the use of naxtarubicin in the near-term.

The Company is currently evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia in the pivotal, adaptive design Phase 3 MIRACLE trial (MB-108). This Phase 3 "MIRACLE" trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) is a global trial, including sites in the US, Europe and the Middle East. Patient dosing has commenced, and the initial data readout is on track for the second half of 2025. For more information about the MIRACLE trial, visit clinicaltrials.gov and reference identifier NCT06788756

Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the European Medicines Agency (EMA).

Kura Oncology to Participate in Bank of America Securities Healthcare Conference

On May 6, 2025 Kura Oncology, Inc. (NASDAQ: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported its participation in Bank of America Securities 2025 Healthcare Conference. Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in a fireside chat at 6:00 p.m. ET / 3:00 p.m. PT on May 13, 2025 (Press release, Kura Oncology, MAY 6, 2025, View Source [SID1234652581]). A live audio webcast of the fireside chat will be available in the Investors section of Kura’s website at www.kuraoncology.com, with an archived replay following the event.

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