On November 24, 2021 BeyondSpring (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, reported that management will participate in a Fireside Chat and host one-on-one investor meetings during the 4th Annual Evercore ISI HealthCONx Conference, taking place November 30-December 2, 2021 (Press release, BeyondSpring Pharmaceuticals, NOV 24, 2021, https://beyondspringpharma.com/beyondspring-pharmaceuticals-to-present-at-the-4th-annual-evercore-isi-healthconx-conference/?utm_source=rss&utm_medium=rss&utm_campaign=beyondspring-pharmaceuticals-to-present-at-the-4th-annual-evercore-isi-healthconx-conference [SID1234596016]). Details for the Fireside Chat can be found below:

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4th Annual Evercore ISI HealthCONx Conference
Date: Tuesday, November 30, 2021
Time: 4:20pm ET
Webcast: Click here
A replay of the Fireside Chat will also be available on BeyondSpring’s website on the Events & Presentations page for 30 days following the conclusion of the conference.

On November 24, 2021 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications including ocular and urologic cancers, reported financial results for the third quarter ended September 30, 2021 (Press release, Aura Biosciences, NOV 24, 2021, View Source [SID1234596015]).

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"We recently completed a successful initial public offering, placing us in a solid financial position to advance our lead VDC, AU-011, through pivotal development for our first indication in the ocular oncology franchise," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. "We are very encouraged with the final data from the Phase 1b/2 trial with intravitreal administration that was presented by Dr. Carol Shields at the AAO annual meeting last week, as well as the continued favorable safety and tolerability profile of the ongoing Phase 2 study with suprachoroidal administration. These data support our plan to move into the pivotal program in 2022 with the goal to develop the first targeted therapy for patients with indeterminate lesions and small choroidal melanoma.

Dr. Pinos continued: "We are also excited to work toward unlocking the broad oncology potential of the VDC platform and plan to initiate clinical development in non-muscle invasive bladder cancer during the second half of next year. Supporting the advancement of our programs, we have a robust balance sheet and a strong team, which we recently built out with several key additions to our management team and Board of Directors."

Recent Pipeline Developments

AU-011 is being developed for the first line treatment of indeterminate lesions and small choroidal melanoma, a life threatening and rare disease with no approved drugs. Data from two clinical trials were recently presented at the American Academy of Ophthalmology (AAO) 2021 Annual Meeting.
Final Phase 1b/2 Data with Intravitreal (IVT) Administration. Data from the completed Phase 1b/2 trial using IVT administration were presented by Dr. Carol Shields, Director, Ocular Oncology Service at Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University. The data demonstrated a statistically significant reduction in tumor growth rate (-0.483 mm/yr, p = 0.018), a 64% tumor control rate, and a visual acuity preservation rate of 71%, which is a dramatic improvement compared to the current standard of care with radiotherapy. These three endpoints have been agreed upon with FDA and will be used in the pivotal program.
Interim Phase 2 Safety Data with Suprachoroidal (SC) Administration. Preliminary results presented by Dr. Hakan Demirci, Professor of Ophthalmology at Kellogg Eye Center, University of Michigan, demonstrate a favorable safety and tolerability profile for AU-011 with SC administration. The data showed no treatment-related serious adverse events, dose limiting toxicities, or grade 3/4 adverse events. Aura plans to present 6-12 months safety and efficacy data from this trial in 2022.
Aura plans to select the route of administration and treatment regimen to initiate the pivotal program in the second half of 2022.
Leveraging the broad tumor targeting capabilities of the VDC platform, Aura is planning to pursue clinical development of AU-011 in non-muscle invasive bladder cancer (NMIBC).
NMIBC is an area of high unmet need with no approved targeted therapies. The AU-011 mechanism of action supports the opportunity for use as a first-line treatment either following initial diagnosis and/or Bacillus Calmette-Guerin, BCG, refractory disease. The data from preclinical Investigational New Drug (IND)-enabling studies of AU-011 demonstrated robust efficacy, supporting its clinical development as a single agent or in combination with checkpoint inhibitors. The planned Phase 1a trial will evaluate the safety and early proof of mechanism in the setting, exploring local necrosis and evidence of immune activation, and Aura expects to initiate the trial in the second half of 2022.
Recent Corporate Updates

Completed Initial Public Offering (IPO). In November 2021, Aura closed a successful IPO of 6,210,000 shares of its common stock, which included the full exercise of the underwriters’ option, at a public offering price of $14.00 per share. The aggregate gross proceeds to Aura from the IPO were approximately $86.9 million, before deducting underwriting discounts and commissions and other estimated offering expenses. Aura’s common stock commenced trading on the Nasdaq Global Market on October 29, 2021 under the ticker symbol "AURA".
Antony Mattessich Appointed to the Board of Directors in September 2021. Mr. Mattessich is currently the Chief Executive Officer at Ocular Therapeutix. Prior to Ocular Therapeutix, he was Managing Director of Mundipharma International, based in Cambridge, England. Prior to his time at Mundipharma, Mr. Mattessich ran the U.S. respiratory, dermatology and pediatrics group at Novartis.
Chris Primiano, J.D., Appointed Chief Business Officer in September 2021. Mr. Primiano joined Aura from Karyopharm Therapeutics Inc., where he most recently served as Executive Vice President, Chief Business Officer, General Counsel and Secretary. Mr. Primiano played an important role in transitioning Karyopharm Therapeutics Inc. from 40 employees in a preclinical and early clinical development setting to 400 employees, commercializing XPOVIO (selinexor) across multiple indications.
Third Quarter 2021 Financial Results

As of September 30, 2021, Aura had cash and cash equivalents totaling $81.8 million. Aura raised $86.9 million in gross proceeds from the IPO. Aura believes its current cash and cash equivalents are sufficient to fund the Company’s operations into 2024.
Research and development expenses increased to $6.4 million for the three months ended September 30, 2021 from $2.9 million for the three months ended September 30, 2020, primarily due to progression of clinical trials and ongoing manufacturing development costs for AU-011. In addition, research and development expenses related to personnel increased from growing headcount due to the progression of clinical trials.
General and administrative expenses increased to $2.5 million for the three months ended September 30, 2021 from $0.8 million for the three months ended September 30, 2020. General and administrative expenses include $0.4 million and $0.1 million of stock-based compensation for the three months ended September 30, 2021 and 2020, respectively. The increase was primarily related to an increase in personnel expenses due to an increase in headcount, as well as general increases in audit, legal, consulting and facilities expenses in anticipation of becoming a public company.
Net loss for the three months ended September 30, 2021, was $8.8 million, compared to $3.6 million for the three months ended September 30, 2020.

On November 24, 2021 Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, reported it has entered into an exclusive license agreement (License Agreement), whereby it acquired a worldwide license (excluding China, Taiwan, Macau and Hong Kong) from iX Biopharma Ltd (iX Biopharma) for Wafermine, a sublingual racemic ketamine wafer, and a worldwide license for other sublingual ketamine wafers, delivered using a proprietary fast-dissolving wafer-based drug delivery platform technology known as WaferiX (Press release, Apricus Biosciences, NOV 24, 2021, View Source [SID1234596014]).

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Seelos plans to evaluate sublingual ketamine, now named SLS-003, in pain indications such as chronic neuropathic pain and Complex Regional Pain Syndrome (CRPS) and in additional psychiatric disorders, including post-traumatic stress disorder (PTSD).

The US Food and Drug Administration (FDA) has granted Wafermine Orphan Drug designation for the treatment of CRPS.

"Our licensing of this new program broadens Seelos’ ketamine franchise with a formulation that we believe will be more suitable for chronic dosing in indications like CRPS and PTSD, which are both very difficult indications to treat effectively," said Raj Mehra, Ph.D., Chairman and CEO of Seelos. "The pharmacokinetic, pharmacodynamic and safety profiles of SLS-003 that have been demonstrated to date suggest a formulation with the potential of being prescribed with less restrictions than current formulations. Our team is very excited to be developing both acute, in SLS-002, and a potentially chronic, in SLS-003, ketamine-based therapy programs. We look forward to initiating studies with SLS-003 in 2022 and our recent capital raises have accounted for the expected development costs for initiating studies."

"We are delighted to collaborate with Seelos Therapeutics, whose deep insights in ketamine drug development make them an ideal partner to further the development of Wafermine and the other sublingual ketamine products," said Eddy Lee, Chairman and CEO of iX Biopharma. "Licensing our WaferiX-based pharmaceutical drugs to suitable third parties for development and commercialization is a core strategy to unlock the value of our assets. We are therefore excited that this commercially significant agreement with Seelos is a validation of our ability to deliver on this strategy."

Pursuant to the License Agreement, Seelos will pay iX Biopharma a one-time, upfront fee of $9,000,000, comprised of $3,500,000 in cash and $5,500,000 in restricted shares of Seelos’ common stock for the worldwide license for Wafermine (excluding China, Taiwan, Macau and Hong Kong), the worldwide license for WaferiXTM in other ketamine formulations, and clinical supplies. Seelos will also pay iX Biopharma certain milestone payments contingent on achievement by Seelos of certain development, regulatory and commercial milestones and a low double-digit royalty on future net sales of certain licensed products.

On November 24, 2021 Selvita Group reported that continued dynamic development in each segment of its activity (Press release, Selvita, NOV 24, 2021, View Source;utm_medium=rss&utm_campaign=selvita-group-reports-a-dynamic-increase-in-revenues-for-q3-2021-ytd [SID1234596012]). Commercial revenues from services executed in Poland amounted to EUR 22.8 million and were 23% higher compared to the three quarters of 2020, when these amounted to EUR 19.1 million. In the third quarter alone, those revenues increased by as much as 32% y/y to EUR 8.5 million. Such dynamic growth is the result of developments in the area of drug discovery services and stabilization of the regulatory studies market.

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Fidelta, representing the segment of services executed in Croatia, recorded EUR 20.0 million in revenues from clients in the first three quarters of 2021, with EBITDA of EUR 6.1 million (30.5% margin). In the third quarter of 2021, Fidelta achieved EUR 7.0 million in sales revenues (an increase of 34% y/y), and EBITDA of EUR 2.2 million (a margin of 31.4%).

The bioinformatics segment (Ardigen) closed the three quarters of 2021 with EUR 4.8 million in revenue from clients, as compared to EUR 2.8 million, in the corresponding period of 2020, indicating an increase of 72% EBITDA amounted to EUR 1.2 million (23.8% margin) and was 53% higher than in the previous year. In the third quarter of 2021 alone, revenues from clients amounted to EUR 1.9 million (an increase of 57% y/y), and EBITDA of EUR 0.6 million (a margin of 31.4%).

The reported period highlights a continued growth of services’ sales on foreign markets. With the acquisition of Fidelta, we observe a significant increase in revenues from sales to the customers in the EU and Switzerland, where the Croatian company generates most of its revenues. At the same time, the continued organic development of Selvita and Ardigen was responsible for the significant increase in revenues from sales to the customers in the United States and the United Kingdom.

After three quarters of 2021, revenues from the U.S., the most competitive market in the world, increased by 89% y/y and amounted to EUR 13.5 million. Selvita Group also recorded a significant increase in sales revenues in the U.K., which rose by 128% y/y.

– The first nine months of 2021 were an intense period for us. Since the beginning of the year, we have been working on integration of Selvita and Fidelta services’ offer. We want to make the most of the experience and capabilities that we gained as a result of Fidelta’s acquisition, in order to further develop the Group’s portfolio of services.

We are satisfied with the financial results achieved in all business segments. In the third quarter, revenues from services executed in Poland increased by 32% y/y, Fidelta maintains high profitability, and Ardigen maintains the highest growth dynamics in the Group – comments Bogusław Sieczkowski, co-founder, significant shareholder and Chief Executive Officer of Selvita.

In order to ensure the continued dynamic development of the Company in the coming years, we are constantly strengthening our team and investing in research infrastructure. In July this year, we have initiated the construction of Selvita Research Center in Krakow, at the same time, the adaptation of an additional over 2 000 sq m in Zagreb is close to completion, and we also plan to increase the space in our current locations in Krakow and Poznan. We continue to strengthen our research and sales teams because we are convinced that the best employees are key to our success and further development.

Strong growth in contracting across all business segments allows us to be optimistic about the future. We have no intention to slow down and plan to continue to grow organically, as well as through acquisitions, adds Sieczkowski.

Selvita Group’s backlog for 2021 currently sums up to EUR 65.1 million, which indicates an increase of 22% y/y, including the organic backlog (excl. Fidelta) which grew by 29% compared to the same period last year.

On November 24, 2021 Allorion Therapeutics, a company focusing on next-generation precision medicine for oncology and autoimmune disease, reported the completion of $40M Series A financing (Press release, Allorion Therapeutics, NOV 24, 2021, View Source [SID1234596011]). This financing round is led by Qiming Venture Partners and participated by IDG Capital, Octagon Capital, Firstred Capital, and Elikon Venture. Existing investors – TF Capital and Med-Fine Capital – continued to support in this round.

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The proceeds will be used to support Allorion’s preclinical projects, IND-enabling studies and IND applications of two drug candidates in China and the United States. Allorion will also increase its investment in its platform technologies in the systematic screen for allosteric inhibitors and synthetic lethality targets with matching tool compounds and enhance the clinical and business development teams.

The drug discovery engine of Allorion integrates technological breakthroughs in protein structure, big data, machine learning and gene editing to systematically discover and develop highly selective small molecules, including covalent and allosteric inhibitors of well-validated targets. Allorion has also built a unique synthetic lethality screening platform to expand the scope of targeted therapies for cancer patients, laying a solid foundation for the company’s long-term success. Allorion endeavors in target selection and project execution and upholds high standards of drug discovery and data quality to gain international recognition and collaboration.

Peter Ding, Founder and CEO of Allorion Therapeutics, said, "Over the past year, Allorion has built up R&D capabilities in Boston and Guangzhou and formed a strong management and R&D team. Multiple projects achieved their milestones. The completion of this financing round shows investors’ recognition of the progress and the support for the company’s long-term strategy on highly innovative platforms for best- or first-in-class drug discovery. We are grateful to all the investors for their trust and support. We will continue our efforts in promoting innovative small molecule drugs to clinical research, fulfilling the unmet clinical needs. Allorion will leverage cutting-edge technologies and strive to make precision medicine more precise and accessible to more patients."

Chen Kan, Principal of Qiming Venture Partners, said, "There are huge unmet medical needs for autoimmune disease and cancer therapy globally. Based on data mining and an in-depth understanding of disease biology, Allorion focuses on the early discovery and development of precision medicines. We have confidence in the team’s strong R&D capabilities.. We hope to support Allorion to grow into a globally-recognized company and improve patients’ life quality."