On April 18, 2023 Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial stage biopharmaceutical company developing and commercializing innovative vaccines, will report first quarter 2023 financial results on Tuesday, May 2, 2023, after the U.S. financial markets close (Press release, Dynavax Technologies, APR 18, 2023, View Source [SID1234630235]).

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Dynavax will host a conference call and live audio webcast on Tuesday, May 2, 2023, at 4:30 p.m. ET/1:30 p.m. PT.

The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source A replay of the webcast will be available for 30 days following the live event.

To dial into the call, participants will need to register for the call using the caller registration link. It is recommended that participants dial into the conference call or log into the webcast approximately 10 minutes prior to the call.

On April 18, 2023 Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported that a comparative biochemical analysis identified rivoceranib, its lead investigational drug, as the most selective vascular endothelial growth factor receptor 2 (VEGFR-2) inhibitor when compared with other tyrosine kinase inhibitors (TKIs) with known activity against VEGFR-2 (Press release, Elevar Therapeutics, APR 18, 2023, View Source [SID1234630233]).

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The results of the analysis were shared today in a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 in Orlando.

"Though VEGFR-2 is a known target for anti-cancer therapy, clinical use of VEGFR-2 inhibitors has been challenged by limited efficacy and various side effects, potentially due to low selectivity," said Seong Jang, Elevar’s chief operating officer and the poster’s lead author. "Rivoceranib’s noteworthy selectivity for VEGFR-2 as compared to other TKIs in this biochemical analysis marks a valuable demonstration of its potential as an anti-cancer therapy, as with increased selectivity comes the possibility of more effective VEGFR-2 dosing and diminished toxicity toward unintended targets, both of which are vitally important to the patients who are confronted with disease."

Elevar is developing rivoceranib, an oral TKI, in combination with camrelizumab, a PD-1 inhibitor, as a treatment option for hepatocellular carcinoma (HCC), the most common type of liver cancer; as a monotherapy treatment option for adenoid cystic carcinoma (ACC); and as mono and combination therapies in other tumor cell types.

For the biochemical analysis, the activity of rivoceranib and 10 U.S. Food and Drug Administration (FDA)-approved TKIs with known activity against VEGFR-2 were compared against a panel of 270 kinases.

Noteworthy results:

Rivoceranib retains greater overall activity of non-targeted kinases compared with reference inhibitors.
Substantial differences in overall residual kinase activity were observed across the panel of 270 kinases among the 11 inhibitors. Among all inhibitors profiled, rivoceranib demonstrated the greatest residual kinase activity across the panel of kinases.
Rivoceranib is the most selective inhibitor of VEGFR-2 kinase activity among the tested inhibitors.
Rivoceranib demonstrated >95% inhibition of VEGFR-2, with 54.7% to 99.5% inhibition of only five kinases (i.e., FLT1, FLT4, Ret, PDGFR, and Lyn) detected at both rivoceranib concentrations.
Compared with rivoceranib, all reference inhibitors tested demonstrated activity against a broader array of kinases.
Key conclusions:

Rivoceranib was identified as the most selective inhibitor of VEGFR-2 in the analysis of the inhibitory profiles of rivoceranib and 10 reference inhibitors against a panel of 270 known kinases.
Differences in selectivity among compounds with a similar range of VEGFR-2 kinase inhibition potency are clinically relevant, as toxicities associated with available VEGFR-2 inhibitors are thought to be due in part to their inhibitory effects against kinases outside of the VEGFR family.
With the increased selectivity seen with rivoceranib, more effective targeting of VEGFR-2 may be achieved due to an ability to deliver higher therapeutic doses with fewer off-target toxicities compared to other TKIs.
This increased ability to reach higher drug concentrations could potentially result in greater anti-tumor efficacy as well as a capacity to achieve adequate concentrations of the drug at sites with limited drug penetration, such as brain metastases.
Rivoceranib, as the most selective inhibitor of VEGFR-2, represents an attractive option for improved VEGFR-2 targeting in cancer.
In June 2022, Elevar announced at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting that in its Phase 2 clinical trial (Study RM-202) of rivoceranib monotherapy in patients with progressive recurrent or metastatic ACC, rivoceranib demonstrated clinical effectiveness, as indicated by substantially reduced tumor progression during the six months after rivoceranib treatment compared to the tumor progression during the six months prior to rivoceranib treatment. There are no currently approved therapies for ACC and the trial was the largest to date in ACC to show this level of effectiveness.

Elevar in September 2022 announced during the annual Congress of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) that in its Phase 3 CARES 310 study, camrelizumab plus rivoceranib significantly prolonged overall survival and progression-free survival, and improved overall response rate versus sorafenib, a standard first-line treatment for unresectable HCC. The company intends to submit a New Drug Application (NDA) and Biologics License Application for the combination to the FDA during the first half of 2023.

To learn more, view Elevar’s AACR (Free AACR Whitepaper) poster and visit ElevarTherapeutics.com.

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 hepatocellular carcinoma (HCC) (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 as a first-line treatment for unresectable HCC (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 HCC (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, Hengrui Pharma, under the brand name Aitan.

On April 18, 2023 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology medicine company developing MasterKey therapies designed to overcome limitations of existing therapies by targeting families of oncogenic driver mutations in patients with genetically defined cancers, reported that its President and Chief Executive Officer, David M. Epstein, Ph.D., will present an overview of the Company’s MasterKey programs, including BDTX-1535 and BDTX-4933, at the Stifel 2023 Targeted Oncology Days on Tuesday, April 25, 2023, at 11:00 a.m. ET, being held virtually (Press release, Black Diamond Therapeutics, APR 18, 2023, View Source [SID1234630231]).

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A live webcast of the presentation can be accessed by visiting the investors relations section of the Company’s website at: www.blackdiamondtherapeutics.com. A replay of the webcast will also be available and archived for 90 days following the event.

On April 18, 2023 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company has secured $450 million in committed financing from funds managed by Pharmakon Advisors, LP (Press release, BioCryst Pharmaceuticals, APR 18, 2023, View Source [SID1234630232]). BioCryst has elected to draw $300 million of the $450 million available to the company on the closing date. The remaining $150 million of committed capital can be drawn at the company’s option until September 2024.

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Net proceeds to the company at closing will be approximately $26 million following the repayment of its existing credit facility with Athyrium Capital Management, and fees and expenses associated with the transaction.

The new five-year credit facility bears interest at the 3-month Secured Overnight Financing Rate (SOFR) + 7.00% (subject to a 1.75% floor). BioCryst has the option to pay up to 50% of the interest on the loans advanced on the closing date in-kind for the first six quarters of the term (subject to an increase in margin from 7.00% to 7.25%), allowing the company to defer cash interest payments until after this period. The facility contains no scheduled amortization payments, with all outstanding principal due at the maturity date in 2028. There are no financial covenants associated with the financing.

"This new credit agreement with Pharmakon enhances BioCryst’s already strong financial position by extending our repayment bullet from 2025 to 2028, when we expect our growing ORLADEYO revenues will be much closer to our peak of $1 billion. On the basis of our strong launch execution and future expectations for ORLADEYO, we have been able to secure more favorable financial terms than we had in our initial pre-launch credit agreement, have the flexibility to draw an additional $150 million of non-dilutive capital completely at our option, and have dramatically reduced our dependence on the capital markets," said Anthony Doyle, chief financial officer of BioCryst.

"The BioCryst team is driving extraordinary success with ORLADEYO, and we are excited to support the company and management team as they continue growing to profitability and bring more rare disease medicines to patients," said Pedro Gonzalez de Cosio, chief executive officer of Pharmakon Advisors, LP.

Pharmakon Advisors, LP is a leading investor in non-dilutive debt for the life sciences industry and is the investment manager of the BioPharma Credit funds. Established in 2009, funds managed by Pharmakon Advisors have committed $7.2 billion across 49 investments.

TD Cowen acted as exclusive financial advisor to BioCryst on the transaction. Gibson Dunn acted as legal advisor to BioCryst. Akin Gump acted as legal advisor to Pharmakon Advisors.

On April 18, 2023 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage global biopharmaceutical company focused on using its novel technology platform for drug discovery and development of innovative therapies to improve clinical outcomes for patients with high unmet medical needs, reported a business update and provided results for the year ended December 31, 2022 (Press release, BeyondSpring Pharmaceuticals, APR 18, 2023, View Source;utm_medium=rss&utm_campaign=beyondspring-provides-business-update-and-reports-year-end-2022-financial-results [SID1234630230]).

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"I am pleased to report that BeyondSpring’s subsidiary, SEED Therapeutics, has made significant headway in advancing internal and external collaboration assets with Eli Lilly, achieving on-time delivery of R&D objectives, which triggered milestones and investment payments," said Dr. Lan Huang, Co-Founder, Chairman and CEO of BeyondSpring. "SEED Therapeutics, which specializes in ‘molecular glue’ development with its proprietary targeted protein degradation (TPD) platform for novel drug discovery, continues to attract increased partnering interest."

Dr. Huang continued, "BeyondSpring remains strategically positioned to advance our programs to near-term important inflection points. The Company continues to make progress in advancing our lead drug candidate, Plinabulin, as a ‘pipeline in a drug’ on the regulatory front in the U.S. and in China, and in a number of Plinabulin IIT studies at MD Anderson, Memorial Sloan Kettering and other institutions in the U.S. and China."

Recent Business and Clinical Updates

Business Updates

SEED Milestone Achievements
SEED Therapeutics received investment payment in June 2022 and milestone payment in February 2023 for pre-clinical development from Eli Lilly, totaling $7 million.

Plinabulin
In March 2023, BeyondSpring withdrew its NDA submission for the CIN indication from China’s National Medical Products Administration (NMPA) review. The Company will continue to communicate with the NMPA regarding its re-filing of the NDA for the CIN indication and plan to re-file the NDA by mid-2023. In addition, the Company plans to submit the NDA for the NSCLC indication with the NMPA by mid-2023.

Clinical Updates

Conference Presentations at ASH (Free ASH Whitepaper), SABCS, and ESMO (Free ESMO Whitepaper) Asia for Plinabulin
In December 2022, the Company exhibited two posters and gave one oral presentation on positive data with Plinabulin for the prevention of docetaxel-induced neutropenia (DIN) in patients with NSCLC and breast cancer at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Congress and San Antonio Breast Cancer Symposium (SABCS).
Enrollment Completion for Three IIT Studies in the U.S. for Plinabulin
In February 2023, the Phase 2 IIT study enrollment was completed for Plinabulin combined with Bristol Myers Squibb’s Opdivo and Yervoy in 2nd/3rd line extensive-stage small cell lung cancer (ES-SCLC) patients who had failed prior immunotherapy. In the Phase 1 IIT study, the preliminary data showed over 40% of tumor response in this population.
In March 2023, the Phase 1 IIT study enrollment was completed for Plinabulin, combined with PD-1 / PD-L1 inhibitors and radiation, in a variety of cancer patients who had failed prior immunotherapies at the MD Anderson Cancer Center.
In March 2023, the Phase 1 IIT study enrollment was completed for Plinabulin in combination with Pegfilgrastim in multiple myeloma (MM) patients who had undergone autologous hematopoietic cell transplantation (AHCT) at the Memorial Sloan Kettering Cancer Center (MSKCC). The topline data will be presented at the upcoming ASCO (Free ASCO Whitepaper) meeting in June 2023.

First Patient Enrollment in Phase 2 IIT Study for Plinabulin Combined with Keytruda and Docetaxel in 2nd/3rd line NSCLC
In March 2023, the first patient was enrolled in a Phase 2 IIT study for Plinabulin in combination with Merck’s anti-PD-1 therapy, Keytruda, and docetaxel for patients with metastatic NSCLC who had failed immunotherapy alone or in combination with platinum-doublet chemotherapy.
Expected Milestones in 2023

Advance a lead SEED-owned new chemical entity (NCE) to the IND-candidate milestone
Advance a second SEED-owned NCE to the Hit milestone with efficacy in animal model
Complete three IIT studies in the U.S. with Topline Data Readout
Plan to Submit NSCLC NDA in China by mid-2023
Plan to Re-submit CIN NDA in China by mid-2023
Full Year 2022 Financial Results

Research and development ("R&D") expenses were $25.6 million for the year ended December 31, 2022, compared to $36.9 million for the year ended December 30, 2021. The $11.3 million decrease was primarily due to lower clinical development expense, lower regulatory fees and professional service expense to support NDA submission and lower personnel costs as a result of the organizational streamlining announced in January 2022.

General and administrative ("G&A") expenses were $13.0 million for the year ended December 31, 2022, compared to $30.7 million for the year ended December 31, 2021. The $17.7 million decrease was primarily due to lower pre-commercialization expenses for Plinabulin and lower personnel costs, as results of the organizational streamlining announced in January 2022. There were also decreases in professional service expenses.

Net loss attributable to the Company was $33.3 million for the year ended December 31, 2022, compared to $64.2 million for the year ended December 31, 2021.

As of December 31, 2022, the Company had cash, cash equivalents, and short-term investments of $37.3 million.