On July 24, 2023 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care, reported that it has entered into a securities purchase agreement to sell in a private placement to institutional investors, led by existing investor Rubric Capital Management LP and including existing and new investors, including Velan Capital, Clearline Capital and Hercules Capital, Inc. (NYSE: HTGC), 20,734,917 shares of its common stock at a purchase price of $1.37 per share, and, to certain investors in lieu of common stock, pre-funded warrants to purchase up to 1,162,891 shares of common stock at a purchase price of $1.3699 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.0001 per share exercise price for each share underlying the pre-funded warrant (Press release, Heron Therapeutics, JUL 24, 2023, View Source [SID1234633385]). Gross proceeds of the private placement are expected to be approximately $30.0 million, before deducting expenses. The private placement is expected to close on or about July 25, 2023, subject to the satisfaction of customary closing conditions.

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Heron intends to use the net proceeds for working capital and general corporate purposes.

The securities being issued and sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any 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 of the Securities Act. Heron has agreed to file a registration statement with the Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock issued in this private placement (the "Resale Shares").

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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 jurisdiction. Any offering of the Resale Shares under the resale registration statement will only be by means of a prospectus.

On July 24, 2023 Hepion Pharmaceuticals presented its corporate presentation (Presentation, Hepion Pharmaceuticals, JUL 24, 2023, View Source [SID1234633384]).

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On July 24, 2023 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported the publication of its Phase 3 CARES 310 study results in The Lancet (Press release, Elevar Therapeutics, JUL 24, 2023, View Source [SID1234633383]). The study assessed the combination of Elevar’s drug candidate rivoceranib, an oral TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line therapy for unresectable hepatocellular carcinoma (uHCC).

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In the randomized, open-label, international trial (NCT03764293), which included 543 patients and was conducted at 95 study sites across 13 countries/regions, camrelizumab plus rivoceranib demonstrated statistically significant and clinically meaningful prolonged overall survival and progression-free survival, and improved overall response rate versus sorafenib, a standard first-line treatment for uHCC.

"As evidenced in the CARES 310 study, camrelizumab plus rivoceranib demonstrate significant promise as a potentially improved therapy for advanced hepatocellular carcinoma," said Saeho Chong, Elevar chief executive officer. "Elevar is pleased The Lancet, a prestigious peer-reviewed journal, recognized the significance of these results as we continue to work toward commercial development of this combined therapy."

Supported by the CARES 310 results, Elevar in May submitted a new drug application to the U.S. Food and Drug Administration (FDA) for camrelizumab plus rivoceranib as a first-line treatment option for uHCC. Rivoceranib was granted a Prescription Drug User Fee Act (PDUFA) date of May 16, 2024. Jiangsu Hengrui Pharmaceuticals Co., Ltd., the developer of camrelizumab, also in May submitted a biologics license application for the drug to the FDA.

With efficacy results generally consistent across all subgroups, the CARES 310 data suggested the combination confers a benefit in a global uHCC population. Also, it demonstrated efficacy among those with hepatitis C virus-based etiology and non-viral etiology, which comprises the majority of U.S. HCC cases1.

Elevar is also developing rivoceranib as a monotherapy treatment option for adenoid cystic carcinoma (ACC), and as mono and combination therapies in other tumor cell types.

To learn more, visit ElevarTherapeutics.com.

1Ghouri YA, Mian I, Rowe JH. Review of hepatocellular carcinoma: Epidemiology, etiology, and carcinogenesis. J Carcinog. 2017 May 29;16:1. doi: 10.4103/jcar.JCar_9_16. PMID: 28694740; PMCID: PMC5490340.

About Hepatocellular Carcinoma (HCC)

HCC is the most common type of primary liver cancer. It accounts for approximately 90% of primary liver cancers and most frequently occurs in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or hepatitis C infection. HCC is often diagnosed at an advanced stage and typically has a poor prognosis and a lack of treatment options and is therefore a condition with an urgent medical need.

About Rivoceranib

Rivoceranib, a small-molecule tyrosine kinase inhibitor (TKI), is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Ongoing clinical studies include uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf). Rivoceranib was the first TKI approved in gastric cancer in China (November 2014). It is also approved in China in combination with camrelizumab as a first-line treatment for uHCC (February 2023). The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in uHCC (U.S.). Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Rivoceranib, under the name apatinib, is also approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese -territory license-holder, Jiangsu Hengrui Pharmaceuticals Company Ltd., (Hengrui Pharma), under the brand name Aitan.

About Camrelizumab

Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in more than 5,000 patients. Currently, 50 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer, and breast cancer, etc.) and treatment settings.

Camrelizumab, under the brand name AiRuiKa, is currently approved for eight indications in China, including monotherapy for the treatment of HCC (second-line), in combination with rivoceranib as a treatment for uHCC (first-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma and nasopharyngeal carcinoma in the first-line setting. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021.

On July 24, 2023 Champions Oncology, Inc. (Nasdaq: CSBR), a leading global technology-enabled biotech that is transforming drug discovery through innovative AI-driven pharmaco-pheno-multiomic integration, reported its financial results for the fiscal year and fourth quarter ended April 30, 2023 (Press release, Champions Oncology, JUL 24, 2023, View Source [SID1234633381]).

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Fourth Quarter and Fiscal Year 2023 Financial and Recent Business Highlights:
•Fourth quarter revenue increased 2% to $13.1 million
•Record annual revenue of $53.9 million, an increase of 10% year-over-year
•Year-over-year fourth quarter and annual bookings increase of 15%
•Announced the formation of our wholly owned bio-tech subsidiary, Corellia AI, to develop novel therapeutics

Ronnie Morris, CEO of Champions, commented, "Overall we had another year of business expansion, developing our platforms and investing in our drug discovery efforts. As mentioned during the year, the down-turn in the economy, and specifically the biotech sector, was going to weigh on our year end results. However, demand for our services reaccelerated and our long term prospects are strong." Morris added, "launching our wholly owned subsidiary, Corellia, to advance our therapeutic discovery initiative is a significant milestone for Champions as we add early stage biotech capabilities utilizing our data to facilitate future growth."

David Miller, CFO of Champions added, "We realized another year of record annual revenue, growing to $54 million, coming in at the low end of our revenue guidance. As addressed during the year, an increase in study cancellations led to revenue growth below our historic performance rates and impacted profitability. While pressures still remain, our pipeline of opportunities has reaccelerated and we remain well positioned for a return to profitability in the second half of the current fiscal year and the long term."

Fourth Fiscal Quarter Financial Results

Total revenue for the fourth quarter of fiscal 2023 was $13.1 million, an increase of 2%, compared to $12.9 million for the same period last year. The increase in revenue was due to continued demand and larger study sizes for our pharmacology studies, including in-vivo and ex-vivo services. Total costs and operating expenses for the fourth quarter of fiscal 2023 were $15.6 million compared to $13.2 million for the fourth quarter of fiscal 2022, an increase of $2.4 million or 18%.

For the fourth quarter of fiscal 2023, Champions reported a loss from operations of $2.5 million, which includes $209,000 in stock-based compensation, $583,000 in depreciation and

Exhibit 99.1
amortization, and an $807,000 asset impairment charge compared to a loss from operations of $311,000, inclusive of $188,000 in stock-based compensation and $568,000 in depreciation and amortization in the fourth quarter of fiscal 2022. Excluding stock-based compensation, depreciation and amortization expenses, and an asset impairment charge, Champions reported an adjusted EBITDA loss for the quarter of $922,000, compared to adjusted EBITDA of $445,000 in the prior year period.

Cost of oncology solutions was $7.3 million for the three months ended April 30, 2023, an increase of $1.1 million, or 18% compared to $6.2 million for the three months ended April 30, 2022. The increase in cost of sales was primarily due to an increase in compensation and lab supply expenses. For the three months ended April 30, 2023, gross margin was 44% compared to 52% for the three months ended April 30, 2022. The lower margin resulted from the increase in compensation which was incurred to support bookings growth that failed to convert to revenue at the expected conversion rates.
Research and development expense was $2.9 million for the three months ended April 30, 2023, an increase of $263,000, or 10%, compared to $2.6 million in the prior year. The increase was primarily due to compensation and lab expenses as we increased investment in our drug discovery program. Sales and marketing expense for the three months ended April 30, 2023 was $1.8 million, an increase of $234,000, or 14%, compared to $1.6 million for the three months ended April 30, 2022. The increase was the result of an increase in compensation and marketing initiatives. General and administrative expense was $2.7 million for the three months ended April 30, 2023 compared to $2.8 million for the three months ended April 30, 2022, a slight decrease of $16,000, or 1%. An asset impairment charge of $807,000 was recorded as a one-time charge to write-off the remaining balance of the capitalized software development costs for our Lumin Bioinformatics SaaS platform.

Net cash used in operating activities for the quarter was approximately $693,000 resulting primarily from an operating loss and changes in our working capital accounts in the ordinary course of business. Net cash used in investing activities was $760,000 primarily from purchases of additional lab equipment. Net cash used in financing activities was approximately $75,000 related to the Company’s stock repurchase program. The Company ended the quarter with a strong cash position of $10.1 million and no debt.

Year-to-Date Financial Results

Total revenue for fiscal year 2023 was $53.9 million, an increase of 10%, compared to $49.1 million for fiscal year 2022. The increase in revenue was due to the expansion of our platforms, business lines, and demand for our services. Total operating expenses increased 22% to $59.1 million for fiscal year 2023, as compared to $48.5 million for the prior year.

For the twelve months ended April 30, 2023, Champions reported a net loss from operations of $5.3 million, inclusive of $864,000 in stock-based compensation expense, $2.2 million in depreciation and amortization expenses, and an asset impairment charge of $807,000 compared to income from operations of $607,000, inclusive of $912,000 in stock-based compensation expense and $1.6 million in depreciation and amortization expenses for the prior year. Excluding stock-based compensation, depreciation and amortization, and asset impairment, Champions reported an adjusted EBITDA loss of $1.3 million for fiscal year 2023 compared to adjusted EBITDA of $3.1 million in the prior year.

Cost of oncology solutions was $29.5 million for the twelve months ended April 30, 2023, an increase of $5.9 million or 25%, compared to $23.6 million, for the twelve months ended April 30, 2022. The increase in cost of oncology services was mainly due to an increase in compensation and supply expenses. Gross margin was 45% for the twelve months ended April 30, 2023 compared to 52% for the twelve months ended April 30, 2022. The lower margin resulted from the increase in compensation which was incurred to support bookings growth that failed to convert to revenue at the expected conversion rates due to an increase in study cancellations.

Research and development expense was $11.5 million for fiscal year 2023, an increase of $2.2 million, or 23%, compared to $9.4 million for the prior year. The increase was mainly due to the investment in therapeutic discovery programs with the increase coming primarily from compensation, lab supply expenses, and early drug development milestone expenses. Sales and marketing expense for fiscal year 2023 was $7.0 million, an increase of $623,000, or 10%, compared to $6.4 million for fiscal year 2022. The increase was primarily due to compensation expense driven by the continued expansion of our business development teams and marketing initiatives, including increased conference attendance due to the easing of Covid restrictions. General and administrative expense was $10.2 million for fiscal year 2023, an increase of $1.1 million, or 12%, compared to $9.1 million for fiscal year 2022. General and administrative expenses were primarily comprised of compensation, insurance, professional fees, IT, and depreciation and amortization expenses. The increase in general and administrative expense was primarily due to increases in IT expenses to support the overall growth of the company and an increase in non-cash depreciation and amortization expenses. A one-time asset impairment charge of $807,000 was recorded to write-off the remaining balance of our capitalized software development costs for our Lumin Bioinformatics SaaS platform.

Net cash generated from operations was $4.0 million for fiscal year 2023. Cash generated from operations was primarily due to changes in working capital accounts in the ordinary course of business and an increase in deferred revenue as a result of strong bookings. Net cash used in investing activities was $2.9 million primarily from investment in additional lab equipment. The Company ended the year in a strong cash position of $10.1 million and has no debt.

Conference Call Information:

The Company will host a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its fourth quarter financial results. To participate in the call, please call 877-545-0523 (domestic) or 973-528-0016 (international) ten minutes ahead of the call and enter the access code 477670. A replay of the call will be available by dialing 877-481-4010 (Domestic) or 919-882-2331 (International) and entering passcode: 48774, or by accessing the investors section of the company’s website within 72 hours.

Full details of the Company’s financial results will be available on, or before, Monday July 24, 2023 in the Company’s Form 10-K at View Source

On July 24, 2023 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported preliminary topline data from its ongoing Phase I clinical trial, COVALENT-101, showcasing initial responses in relapsed/refractory AML patients with menin-dependent mutations (Press release, Biomea Fusion, JUL 24, 2023, View Source [SID1234633380]).

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In the COVALENT-101 study, BMF-219 is orally administered on a daily schedule in continuous 28-day cycles. The preliminary analysis as of July 13, 2023 of Dose Level 4 [500 mg once daily (non-CYP3A4 inhibitor arm) and 125 mg once daily (CYP3A4 inhibitor arm), both producing comparable exposures] showed CRs in 2 of 5 AML patients with known menin-dependent mutations (KMT2Ar/MLL1r, 1 patient; NPM1, 2-patients; MLL-PTD, 1-patient; and NUP98 fusion, 1-patient). These relapsed/refractory patients had a range of prior therapies (1 to 8) and two complete responses (1 CR, 1 CRi) were observed within the first two 28-day treatment cycles with BMF-219. Patients were previously treated with standard-of-care and investigational therapies including allogeneic bone marrow transplant. Both patients who achieved CRs continue on BMF-219 treatment. Dose Level 4 is the first dose level which focused primarily on enrolling patients with known menin-dependent mutations.

BMF-219 has been generally well tolerated with no QTc prolongation reported. At the time of this analysis, a total of 20 AML patients have received BMF-219 during the dose escalation portion of the COVALENT-101 study. Initially, patients were enrolled agnostic to mutational status; subsequently, the study protocol was amended to enrich for patients with AML harboring menin-dependent mutations.

Dose Level 4 was cleared with no dose-limiting toxicities observed, allowing for the continuation of dose escalation. Enrollment for Dose Level 5 has commenced to further optimize and explore the potential to improve upon these preliminary results. Completion of the dose escalation for the acute leukemia cohort is anticipated later this year. Biomea is planning to present additional clinical data from the COVALENT-101 study at an upcoming scientific conference, including comprehensive results from the acute leukemia patients dosed during the escalation phase.

"We are very excited to share these early findings confirming that our targeted, covalently binding menin inhibitor, BMF-219, can elicit profound and rapid responses in patients with menin inhibitor-sensitive acute leukemia even at this dose level, which we believe we can further build on," said Steve Morris, MD, Biomea’s Chief Medical Officer. "Notably these complete remissions were achieved within the first two cycles of BMF-219 therapy in relapsed/refractory AML patients who had limited therapeutic options and an overall poor prognosis. We are continuing to dose escalate and are looking forward to identifying the recommended Phase 2 dose within the next several months."

About BMF-219
BMF-219 is a covalently binding inhibitor of menin, a protein known to play an essential role in oncogenic signaling in genetically defined leukemias as well as in diabetes. Preclinically, BMF-219 has demonstrated in well-established acute leukemia cell lines robust downregulation of key leukemogenic genes in addition to menin itself. Additionally, BMF-219 has shown anticancer efficacy in multiple in vitro, in vivo, and ex vivo models of acute leukemia, multiple myeloma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia. BMF-219 is currently being evaluated in first-in-human clinical trials enrolling patients with specific menin-dependent mutations in liquid and solid tumors as well as patients with diabetes.

About COVALENT-101
COVALENT-101 is a Phase I, open-label, multi-center, dose-escalation and dose-expansion study designed to assess the safety, tolerability, and pharmacokinetics/pharmacodynamics of oral dosing of BMF-219 in patients with relapsed/refractory (R/R) acute leukemias —including subpopulations where menin inhibition is expected to provide therapeutic benefit (e.g., patients with MLL1/KMT2A gene rearrangements or NPM1 mutations). The study is designed to enroll subsets of acute leukemia patients who are receiving a CYP3A4 inhibitor and also those not receiving a CYP3A4 inhibitor. COVALENT-101 is also investigating the dosing of BMF-219 in other patient populations where preclinical studies have shown high menin dependence, such as multiple myeloma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. Additional information about this Phase I clinical trial of BMF-219 can be found at ClinicalTrials.gov using the identifier NCT05153330.

About Acute Myeloid Leukemia (AML)
AML is the most common form of acute leukemia in adults and represents the largest number of annual leukemia deaths in the U.S. and Europe. AML originates within the white blood cells in the bone marrow and can rapidly move to the blood and other parts of the body, including the spleen, central nervous system, and other organs. Approximately 30,000 people in the U.S. and Europe are diagnosed with AML each year, and the five-year overall survival rate in adults is roughly 29%. Among patients with relapsed/refractory disease, the need is greatest, as the overall survival is only approximately 3 to 9 months. It is estimated that upwards of 45% of AML patients have menin-dependent genetic drivers (MLL1-r, NPM1 mutant, and certain additional less common but recurrent gene mutations).