On October 28, 2021 PharmaMar Group (MSE: PHM) reported that recurring revenues, comprising net sales plus royalties received from sales by our partners, increased by 31% year-on-year to €119 million for the first 9 months of the year (Press release, PharmaMar, OCT 28, 2021, View Source [SID1234596672]).

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As in previous quarters, the increase in recurring revenues was mainly driven by the good performance of our oncology business unit. Oncology sales revenues reached €88.7 million year-to-date in 2021, an increase of 21% compared with the same period last year.

It is worth highlighting the growth in revenues from Zepzelca (lurbinectedin) in Europe under the compassionate use authorization program, which amounted to €23.3 million through September 30th. This represents an increase of 77.7% when compared with the same period last year. Yondelis (trabectedin) sales remained stable in 9M 2021, €56.5 million compared to €57.1 million in 9M 2020.

Royalty revenues amounted to €27.2 million in 9M 2021, compared to €7.4 million over the same period in 2020. This significant increase was mainly driven by royalties received from our partner Jazz Pharmaceuticals, which accounted for €25.2 million and have been entirely generated as a result of sales of lurbinectedin in the US. As our partner Jazz Pharmaceuticals has not reported its 3Q 2021 results yet, our recorded 3Q 2021 royalties are an estimate based on our conservative, best available information.

Revenues from licensing agreements refer, both in 2020 and in 2021, to the licensing agreement signed with Jazz Pharmaceuticals in 2019, reaching €24.4 million in 3Q 2021, and €130.4 million in 3Q 2020. This difference is due to the recording as revenue of the upfront payment for the license agreement, as well as the milestone for the approval of lurbinectedin in the US. Both events occurred in the first half of 2020 and are being recognized on the income statement, based on the degree of progress of the contractual commitments.

PharmaMar plans to commence a confirmatory trial with lurbinectedin in second-line recurrent Small-Cell Lung Cancer at the end of 2021. This will be a three-arm clinical trial comparing lurbinectedin in monotherapy or in combination with irinotecan, versus the investigators’ choice of irinotecan or topotecan. If positive, this trial will be used with the US FDA to confirm the benefit of lurbinectedin in the treatment of Small-Cell Lung Cancer when patients progress after first-line treatment with a platinum-based regimen, as well as with the European Medicine Agency as a registration trial in Europe.

GENOMICA, PharmaMar Group’s molecular diagnostics company, reported net revenues of €3.5 million up to September 30th, 2021, compared to €10.5 million in the same period of 2020. This difference was mainly due to increased competition in the market for COVID-19 tests, both PCR, lateral flow and antibody tests, which led to lower prices. Similarly, the decrease in the incidence of COVID-19 has considerably reduced the use of these tests.

As a result, PharmaMar Group’s total revenues for the first 9 months of 2021 amounted to €143.9 million, compared to €222.2 million over the same period of 2020, which, as mentioned above, included the upfront payment for the licensing agreement with Jazz Pharmaceuticals and the milestone payment for the approval of
lurbinectedin in the US.

The Group’s R&D expenditure increased by 21.2% to €47.4 million during the first nine months of 2021, compared with €39.1 million in the same period last year.

As a result, PharmaMar Group posted a net profit of €54.7 million on September 30th, 2021.

As of September 30th, 2021, the PharmaMar Group had cash, and cash equivalents, plus financial investments of €222.0 million and a total debt of €50.7 million. As a result, total net cash amounted to €171.3 million.

Earnings conference call for analysts and investors

PharmaMar will hold a conference call with analysts and investors on Friday, October 29th at 1:00 pm (CEST). The numbers to connect to the teleconference are +34 91 901 16 44 (from Spain), +1 646 664 1960 (from the US or Canada) or +44 20 3936 2999 (other countries). Participant access code: 296923.

The teleconference and recording will be available on PharmaMar’s website, by visiting the Events Calendar section of the company’s website at www.pharmamar.com.

On October 28, 2021 Pascal Biosciences Inc. reported a non-brokered private placement financing of up to 9,000,000 units (each a "Unit") of securities at a price of $0.10 per Unit for aggregate gross proceeds of up to $900,000.00 (the "Offering") (Press release, Pascal Biosciences, OCT 28, 2021, View Source [SID1234596244]). Each Unit will be comprised of one (1) common share and one (1) non-transferable common share purchase warrant, with each whole warrant entitling the holder to purchase one additional common share at a price of $0.15 for two years from the closing date of the private placement. The exercise term of the warrant will be accelerated in the event the closing price of the Shares is above $0.20 for ten consecutive days and will be exercisable for a period of 15 days from the date of receipt by investors of a Notice of Acceleration. Finder’s fees of up to 10% may be paid.

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The Company is continuing with the process of raising the funds and has filed for conditional acceptancy by the TSX.V

All securities issued will be subject to a four month holding period which will expire on the date that is four months and one day from the date of issue.

Our agreement with SoRSE Technology, which was initiated August 15, 2020, was completed on Nov. 15.

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On October 28, 2021 Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company developing transformative, targeted therapeutics to treat life-threatening cancers, reported recent corporate updates and financial results for the third quarter ended September 30, 2021 (Press release, Aravive, OCT 28, 2021, View Source [SID1234594066]).

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"During the third quarter, we expanded our clinical oncology pipeline with the initiation of a Phase 1b trial of batiraxcept (AVB-500) for the treatment of pancreatic adenocarcinoma," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "Aravive is now advancing three clinical trials for life threatening cancers with unmet medical needs. We look forward to presenting new preliminary data from our Phase 1b trial of batiraxcept in clear cell renal cell carcinoma at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November. We remain optimistic about the broad potential of batiraxcept to improve the lives of people living with cancer."

Recent Corporate Highlights

Batiraxcept (AVB-500) in Platinum Resistant Ovarian Cancer (PROC): As a result of the evolving pandemic and other factors, the pace of enrollment in the registrational Phase 3 clinical trial of batiraxcept in PROC has been slower than originally anticipated. Aravive now expects to conduct the interim analysis in mid-2022. The interim analysis is being conducted to determine whether randomization will continue with all patients, regardless of prior bevacizumab treatment, or only with patients medically ineligible to receive bevacizumab or who chose not to receive bevacizumab. The final analysis of the primary endpoint preserves the opportunity to evaluate the efficacy in patients who received bevacizumab prior to study entry, as well as those patients who never received bevacizumab. This provides an additional opportunity to be successful in both patient populations, regardless of the results of the interim analysis. The global, randomized, double-blind, placebo-controlled adaptive trial is designed to evaluate efficacy and safety of batiraxcept at a dose of 15 mg/kg in combination with paclitaxel versus paclitaxel alone.

In October, the European Commission granted orphan drug designation to batiraxcept for the treatment of PROC. Orphan drug designation is granted for medicines being developed for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 people in the European Union.
Batiraxcept in Clear Cell Renal Cell Carcinoma (ccRCC): Aravive plans to present new preliminary data from the Phase 1b portion of its Phase 1b/2 clinical trial of batiraxcept in ccRCC at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting on November 13, 2021. The Company previously announced positive initial safety, pharmacokinetic and pharmacodynamic results from three patients dosed with 15 mg/kg of batiraxcept in combination with cabozantinib in the Phase 1b portion of the trial. Aravive expects to complete enrollment in the Phase 1b portion of the trial and initiate the Phase 2 portion of the trial in the fourth quarter of 2021.

Batiraxcept in Pancreatic Adenocarcinoma: In August 2021, Aravive dosed the first patient in the Phase 1b portion of its Phase 1b/2 trial of batiraxcept in combination with gemcitabine and nab-paclitaxel as a first-line treatment in patients with advanced or metastatic pancreatic adenocarcinoma. The Phase 1b portion of the clinical trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of batiraxcept in combination with gemcitabine and nab-paclitaxel. The Company expects to complete enrollment in the Phase 1b portion of the trial in the first half of 2022 and initiate the Phase 2 portion of the trial in the second half of 2022.

Achieved Second Development Milestone with 3D Medicines: In July 2021, Aravive achieved a $3.0 million development milestone based on the Center for Drug Evaluation of the China National Medical Products Administration approval of the Investigational New Drug application submitted by 3D Medicines Inc. to participate in Aravive’s registrational Phase 3 clinical trial of batiraxcept in PROC. The Company received the $3.0 million development milestone payment in the third quarter of 2021. Under the terms of the collaboration and license agreement with 3D Medicines, Aravive is eligible to receive up to an aggregate of $207 million in development and commercial milestone payments and royalties.
Third Quarter 2021 Financial Results
Revenue for the three and nine months ended September 30, 2021 were $2.4 million and $6.5 million, respectively, compared to $0 for both periods in 2020. Revenue for the three and nine months ended September 30, 2021 was derived solely from the Company’s collaboration and license agreement with 3D Medicines and represents a portion of initial signing and milestone payments received from 3D Medicines that is recognized at the time of the receipt and a portion of the payments that is deferred and recognized over the PROC trial period.

Total operating expenses for the three and nine months ended September 30, 2021 were $14.0 million and $33.4 million, respectively, compared to $10.7 million and $26.7 million for the same periods in 2020.

Total operating expenses for the three and nine months ended September 30, 2021 included non-cash stock-based compensation expense of $0.6 million and $1.7 million, respectively, compared to $0.4 million and $1.6 million for the same periods in 2020. In addition, during the nine months ended September 30, 2020, there were non-recurring non-cash charges for impairment of the Company’s right-of-use asset and leasehold improvements of $5.8 million.

For the three and nine months ended September 30, 2021, Aravive reported a net loss of $11.1 million and $26.2 million, or $0.53 per share and $1.33 per share, respectively, compared to a net loss of $10.7 million and $26.5 million, or $0.66 per share and $1.69 per share, for the same periods in 2020.

Cash Position
As of September 30, 2021, cash and cash equivalents were $67.5 million, compared to $60.5 million as of December 31, 2020. Based upon its current operating plan and balance sheet as of September 30, 2021, Aravive expects to have sufficient cash to be able to fund the base operating plan into the second half of 2022.

About Batiraxcept (Formerly AVB-500)
Batiraxcept is a therapeutic recombinant fusion protein that has been shown to neutralize GAS6 activity by binding to GAS6 with very high affinity in preclinical models. In doing so, batiraxcept selectively inhibits the GAS6-AXL signaling pathway, which is upregulated in multiple cancer types including ovarian, renal and pancreatic cancer. In preclinical studies, GAS6-AXL inhibition has shown anti-tumor activity in combination with a variety of anticancer therapies, including radiation therapy, immuno-oncology agents, and chemotherapeutic drugs that affect DNA replication and repair. Increased expression of AXL and GAS6 in tumors has been correlated with poor prognosis and decreased survival and has been implicated in therapeutic resistance to conventional chemotherapeutics and targeted therapies. Batiraxcept is currently being evaluated in multiple clinical trials and has been granted Fast Track designation by the U.S. Food and Drug Administration and orphan drug designation by the European Commission in platinum resistant recurrent ovarian cancer. Analysis of all safety data to date showed that batiraxcept has been generally well tolerated with no dose-limiting toxicities or unexpected safety signals.