On January 30, 2025 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders, reported the pricing of a public offering of an aggregate of 1,666,666 shares of its common stock (or common stock equivalents in lieu thereof), Series A warrants to purchase up to 1,666,666 shares of common stock and Series B warrants to purchase up to 1,666,666 shares of common stock, at a combined public offering price of $3.00 per share (or per common stock equivalent in lieu thereof) and accompanying warrants (Press release, Enveric Biosciences, JAN 30, 2025, View Source [SID1234649955]). The warrants will have an exercise price of $3.00 per share and will be exercisable immediately. The Series A warrants will expire five years from the date of issuance and the Series B warrants will expire eighteen months from the date of issuance. The closing of the offering is expected to occur on or about February 3, 2025, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses payable by the Company, are expected to be approximately $5 million. The Company intends to use the net proceeds from this offering for product development, working capital and general corporate purposes.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-284277), which was declared effective by the Securities and Exchange Commission (the "SEC") on January 30, 2025. The offering is being made only by means of a prospectus forming part of the effective registration statement relating to the offering. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, 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.

On January 30, 2025 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported its participation in a fireside chat at the Guggenheim SMID Cap Biotech Conference in New York on Wednesday, February 5, 2025 at 9:30 a.m. ET (Press release, Cogent Biosciences, JAN 30, 2025, View Source [SID1234649953]).

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A live webcast can be accessed on the Investors & Media page of Cogent’s website at View Source A replay will be available approximately two hours after the completion of the events and will be archived for up to 30 days.

On January 30, 2025 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, reported that Jeffrey Stein, Ph.D., President and Chief Executive Officer, will participate in the Guggenheim Securities SMID Cap Biotech Conference (Press release, Cidara Therapeutics, JAN 30, 2025, View Source [SID1234649952]).

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Details are as follows:

Event: Guggenheim Securities SMID Cap Biotech Conference
Date: Wednesday, February 5, 2025
Time: 1:30 PM ET
Format: Fireside chat
Webcast: View Source

A replay of the presentation will be available in the Investors section on the Company’s website at www.cidara.com. The replay of the presentation will be available for 90 days.

Cidara will also participate in one-on-one investor meetings during this event. Investors interested in meeting with Cidara at the conference should contact their Guggenheim representative directly.

On January 30, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its consolidated financial results for the fiscal year ended December 31, 2024, and forecasts for the fiscal year ending December 31, 2025 (Press release, Chugai, JAN 30, 2025, View Source [SID1234649951]).

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"In 2024, Chugai marked record high revenue, operating profit, and net income. Despite the decrease in domestic sales due to impact of the completion of government supply of Ronapreve for COVID-19, NHI drug price revisions and penetration of biosimilars, the greatly increased export of Hemlibra to Roche and other factors contributed to the growth. In R&D, this year saw many achievements of global approvals for our in-house products. PiaSky obtained initial approval for the treatment of paroxysmal nocturnal hemoglobinuria, and Alecensa obtained approval for the additional indication of adjuvant treatment of non-small cell lung cancer in Japan, the United States, Europe and China. In addition, NEMLUVIO, out-licensed to Galderma, obtained approval for the treatment of prurigo nodularis and atopic dermatitis in the United States. In early development of in-house projects, NXT007 and AMY109 proceeded to phase II clinical trials, and several projects including GYM329, DONQ52 and RAY121, have started new clinical trials. Furthermore, BRY10 marked the first project to enter the clinical development stage, which utilized Chugai’s proprietary AI-based antibody drug discovery support technology, MALEXA. Chugai Venture Fund, which became fully operational in 2024, is implementing multiple investments that are expected to strengthen our company’s technology and drug discovery capabilities. 2025 marks the 100-year anniversary of the company’s founding. With the aspiration of ‘Creating drugs that benefit the world’ which has been consistently carried from the time of our founding, and by focusing on our unique science and technology capabilities and creating our unique innovation, Chugai will strive in the next 100 years, to continue to expand the benefit of medical community and human health around the world for the sake of patients," said Dr. Osamu Okuda, Chugai’s President and CEO.

Chugai reported that revenue for the fiscal year ended December 2024 totaled ¥1,170.6 billion (+ ¥59.2 billion, +5.3%, YoY).

Domestic sales were ¥461.1 billion (- ¥96.9 billion, -17.4%, YoY). In the oncology field, although our new product Phesgo performed well, products including our mainstay product Avastin were affected by NHI drug price revisions and biosimilars. Also, sales of Perjeta and Herceptin fell along with the market penetration of Phesgo which includes the same active pharmaceutical ingredients, resulting in a decrease by 4.8% compared to the previous year. In the specialty field, sales decreased by 28.3% compared with previous year, mainly due to the completion of supply of Ronapreve to the government, despite that our new product Vabysmo grew and our mainstay products Hemlibra and Actemra performed well. Overseas sales were ¥536.8 billion (+ ¥120.3 billion, +28.9%, YoY), driven by a substantial increase in exports of Hemlibra to Roche. Other revenue increased by 26.2% mainly due to increase in one-time income, etc., in addition to the increase in income related to Hemlibra.

Cost to sales ratio improved by 8.4 percentage points year-on-year to 33.9%, mainly due to a change in the product mix. Research and development expenses amounted to ¥176.9 billion (+8.7%, YoY) due to investments into drug discovery and early development, and the progress of development projects. Selling, general and administration expenses were comparable to the previous year, amounting ¥102.2 billion (+0.2%, YoY). For other operating income (expense), an income of ¥2.7 billion was recorded, mainly due to the recognition of income from disposal of product rights. As a result, Core operating profit totaled ¥556.1 billion (+ ¥105.4 billion, +23.4%, YoY), which marked the first time exceeding ¥500.0 billion, and Core net income increased to ¥397.1 billion (+ ¥63.5 billion, +19.0%, YoY).

Reflecting the favorable results and based on our principles of "a stable allocation of profit" and "aiming for a consolidated dividend payout ratio of 45% on average in comparison with Core EPS," year-end dividends for the fiscal year ended December 31, 2024 are planned to be ¥57 per share. As a result, the annual dividend per share will be ¥98 per share, and the Core dividend payout ratio is 40.6% (an average of 40.3% for the past five years).

Regarding research and development, Chugai made good progress in both early and late-stage development toward achieving TOP I 2030. Chugai made important progress in both in-house and in-licensed products, and in addition, through new investments, Chugai strengthened its efforts to create innovative solutions.

For in-house projects that will drive mid to long-term growth, NXT007 and AMY109, both applying Chugai’s proprietary antibody engineering technologies, have entered Phase II clinical trials. Additionally, RAY121 (for autoimmune diseases), BRY10 (for chronic diseases), GYM329 (for neurological disorders and obesity), and DONQ52 (for celiac disease) each have entered new clinical trials. In late-stage projects, PiaSky, a treatment for paroxysmal nocturnal hemoglobinuria, was launched in Japan and approved in the U.S., Europe, and China. Alecensa was approved for expanded indication as post-operative adjuvant therapy for ALK-positive non-small cell lung cancer in Japan, the U.S., Europe, China and Taiwan.

In-house products out-licensed to third parties excluding Roche also progressed steadily. NEMLUVIO (nemolizumab), being developed overseas by Galderma, has advanced significantly as a global product, having been approved for prurigo nodularis and moderate-to-severe atopic dermatitis in the U.S. and having been recommended for approval for the same indications by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). Avutometinib, out-licensed to Verastem Oncology, has been accepted for review of the New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) for accelerated approval in KRAS-mutant recurrent low-grade serous ovarian cancer and has been granted Priority Review.

As for projects in-licensed from Roche, Lunsumio has received regulatory approval in Japan for relapsed or refractory follicular lymphoma. Elevidys (SRP-9001), Chugai’s first gene therapy product, has been filed with a regulatory application in Japan for Duchenne muscular dystrophy. Vabysmo and Evrysdi received approvals for expanded indications, and Tecentriq filed an application for expanded indication.

In 2024, to further accelerate our drug discovery engine through open innovation, Chugai Venture Fund, LLC made investments in Leal Therapeutics, HYKU Biosciences, and one other company, strengthening Chugai’s efforts in creating innovative solutions.

In 2025, Core revenues, Core operating profit, and Core net income are expected to be ¥1,190.0 billion (+ ¥19.4 billion, +1.7%, YoY), ¥570.0 billion (+ ¥13.9 billion, +2.5%, YoY), and ¥410.0 billion (+ ¥12.9 billion, +3.2%, YoY), resulting in an increase in both revenues and profits. Sales are expected to increase in Japan and overseas, totaling ¥1,018.0 billion (+ ¥20.1 billion, +2.0%, YoY). Domestic sales are expected to be ¥462.5 billion (+ ¥1.4 billion, +0.3%, YoY), including increase in volume of new product Phesgo, PiaSky and our mainstay products. Overseas sales are expected to be ¥555.5 billion (+ ¥18.7 billion, +3.5%, YoY) due to growth in sales of Hemlibra, Alecensa and NEMLUVIO, despite decrease in Actemra. Other revenues are expected to be ¥172.0 billion (- ¥0.7 billion, -0.4%, YoY). Royalty and profit-sharing income are forecasted to increase to ¥165.7 billion (+ ¥18.3 billion, +12.4%, YoY), due to an increase in income related to Hemlibra, despite a decrease in income related to Actemra. On the other hand, other operating income is expected to decrease to ¥6.3 billion (- ¥19.0 billion, -75.1%, YoY), due to a decrease in one time income.

For the following fiscal year ending December 31, 2025, Chugai expects annual dividends of ¥100 in regular dividends (interim dividends of ¥50 and year-end dividends of ¥50) and ¥150 as special dividends for the company’s 100th anniversary (interim dividends of ¥75 and year-end dividends of ¥75) for a total of ¥250 per share. As a result, the Core dividend payout ratio for 2025 is expected to be 100.0% (54.1% on a five-year average basis).

[2024 full year results]

Billion JPY 2024 2023 % change
Core results
　Revenue 1,170.6 1,111.4 +5.3%
　　Sales 997.9 974.5 +2.4%
　　Other revenue 172.7 136.9 +26.2%
　Operating profit 556.1 450.7 +23.4%
　Net income 397.1 333.6 +19.0%
IFRS results
　Revenue 1,170.6 1,111.4 +5.3%
　Operating profit 542.0 439.2 +23.4%
　Net income 387.3 325.5 +19.0%
[Sales breakdown]

Billion JPY 2024 2023 % change
Sales 997.9 974.5 +2.4%
　Domestic sales 461.1 558.0 -17.4%
　　Oncology 247.7 260.2 -4.8%
　　Specialty 213.4 297.8 -28.3%
　Overseas sales 536.8 416.5 +28.9%
[Oncology field (Domestic) Top5-selling medicines]

Billion JPY 2024 2023 % change
　Tecentriq 65.4 65.5 -0.2%
　Polivy 34.1 35.5 -3.9%
　Avastin 33.8 49.8 -32.1%
　Alecensa 31.0 30.3
+2.3%

　Phesgo 23.5 0.7 34times
[Specialty field (Domestic) Top5-selling medicines plus Ronapreve]

Billion JPY 2024 2023 % change
　Hemlibra 59.0 54.8 +7.7%
　Actemra 48.0 44.3 +8.4%
　Enspryng 24.7 23.9 +3.3%
　Vabysmo 21.5 15.3 +40.5%
　Evrysdi 15.9 14.5 +9.7%
　Ronapreve* - 81.2 -100.0%
*Ronapreve has not been listed in the National Health Insurance (NHI) price list.

[2025 full year forecast]

Billion JPY 2025 Forecast 2024 Actual % change
Core-basis
　Revenue 1,190.0 1,170.6 +1.7%
　Operating profit 570.0 556.1 +2.5%
　Net income 410.0 397.1 +3.2%
[Progress in R&D activities from Oct 26th, 2024 to Jan 30th, 2025]

2024 FY R&D Progress
About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting Non-Core items to IFRS results. Chugai’s recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and as the basis for payment-by-results such as a return to shareholders.

Trademarks used or mentioned in this release are protected by law.

On January 29, 2025 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC), reported the publication of an article entitled "Effects of Lasofoxifene Versus Fulvestrant on Vaginal and Vulvar Symptoms in Patients with ESR1-Mutated, ER+/HER2-, Metastatic Breast Cancer from the ELAINE-1 Study," in the peer-reviewed journal Clinical Breast Cancer (Press release, Sermonix Pharmaceuticals, JAN 29, 2025, View Source [SID1234649982]).
The previously reported Phase 2 Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE-1) study (NCT03781063) was an open-label, randomized trial evaluating the efficacy and safety of lasofoxifene versus fulvestrant. In the study of women with ESR1-mutant breast cancer who previously had aromatase inhibitor-CDK4/6is, 52 women were randomized to lasofoxifene and 51 to fulvestrant, with progression-free survival (PFS) as the primary endpoint. Lasofoxifene monotherapy had numerically greater PFS (median 5.6 vs 3.7 months; P=0.138; hazard ratio [HR] 0.669 [95% CI, 0.434-1.125]), objective response rate (ORR, 13.2% vs 2.9%; P=0.124), and clinical benefit rate (CBR, 36.5% vs 21.6%; P=0.117) versus fulvestrant. The small sample size of this Phase 2, signal-seeking study limited the statistical power. A favorable safety profile was reported in both treatment groups.1
In this secondary endpoint analysis just published, patients treated with investigational lasofoxifene – but not fulvestrant – demonstrated improved vaginal and vulvar symptoms of dryness and pain as assessed by the validated vaginal and vulvar symptom scale (VAS and VuAS) patient-reported outcome instrument.
"Recent progress in breast cancer management is leading to improved patient outcomes and longevity. Sermonix is highly focused on advancing oral lasofoxifene to hopefully build on that progress and to potentially improve patient quality of life particularly around urogenital health, an issue important to many patients and couples coping with current breast cancer treatments," said Dr. David Portman, Sermonix founder and chief executive officer. "While lasofoxifene has been previously studied in healthy post-menopausal women with urogenital syndrome of menopause, it has not been explored in a population with advanced breast cancer. We are very pleased that Clinical Breast Cancer, a prestigious peer-reviewed journal, recognized the importance of the results from ELAINE-1 and the need for further research in this area."

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Results: Of 103 enrolled patients, 72 (70%) completed the mean vaginal (VAS) and vulvar (VuAS) assessment scales (mean age 61.5 years). Vaginal (40%)/vulvar (25%) dryness and vaginal pain (22%) were the most frequently reported symptoms; 26% reported ≥1 moderate/severe symptom. Lasofoxifene decreased the mean composite VAS/VuAS, VAS, and VuAS from baseline to week 16 by 74%, 74%, and 79%, respectively, while fulvestrant increased them by 36%, 15%, and 63%, respectively. Baseline vaginal/vulvar symptoms were more severe if patients were under age 40, had no visceral disease, used adjuvant tamoxifen previously, or had a longer duration of AI use in the adjuvant/metastatic settings.
The currently enrolling Phase 3, registrational, ELAINE-3 trial (NCT05696626) comparing the efficacy and safety of lasofoxifene plus abemaciclib to fulvestrant plus abemaciclib will incorporate the FACT B-Endocrine Symptoms scale to further explore the potential impact of treatment on vaginal dryness, painful intercourse, sexual interest and other quality-of-life domains.
The open-access Clinical Breast Cancer paper can be accessed online here.
To learn more about Sermonix Pharmaceuticals and lasofoxifene, visit View Source To learn more about the ELAINE studies, visit View Source
Goetz MP et al Annals of Oncology 2023;34:1141-1151

About Lasofoxifene
Lasofoxifene is an investigational novel endocrine therapy in clinical development which has demonstrated robust target engagement as an ESR1 antagonist in the breast, particularly in the presence of ESR1 mutations. Lasofoxifene has demonstrated anti-tumor activity as monotherapy and in combination with a CDK4/6 inhibitor in Phase 2 studies and has unique tissue selectivity distinguishing it from other current and investigational endocrine therapies, with beneficial effects seen on vagina and bone in previous clinical studies. Lasofoxifene, which Sermonix licensed globally from Ligand Pharmaceuticals Inc., has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a novel targeted and tissue selective oral endocrine therapy, could, if approved, play a critical role in the precision medicine treatment of advanced ER+ breast cancer.