On November 12, 2021 BeyondSpring (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, reported that management will present at and host one-on-one investor meetings during the virtual portion of the Jefferies London Healthcare Conference, taking place November 18-19, 2021 (Press release, BeyondSpring Pharmaceuticals, NOV 12, 2021, View Source;utm_medium=rss&utm_campaign=beyondspring-pharmaceuticals-to-present-at-the-2021-jefferies-london-healthcare-conference [SID1234595381]).

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The presentation will be available on-demand for attendees during the virtual conference beginning on November 18, 2021. Investors who would like to view the presentation or request a meeting with management may do so by clicking on the link and registering for the event HERE.

A replay of the presentation will also be available on BeyondSpring’s website on the Events & Presentations page for 30 days following the conclusion of the conference.

On November 12, 2021 AstraZeneca reported that double-digit revenue growth from its Oncology, CVRM1 and R&I2 medicines, and established its Rare Disease capability with the acquisition of Alexion Pharmaceuticals Inc. (Alexion) (Press release, AstraZeneca, NOV 12, 2021, View Source [SID1234595380]). Rare disease is a high-growth area with rapid innovation and significant unmet medical need.

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Since June, AstraZeneca has made significant progress with its late-stage pipeline, reporting eight positive Phase III trial results and the approval of Saphnelo (anifrolumab) in the US for the treatment of systemic lupus erythematosus, and Ultomiris in the EU for children and adolescents with paroxysmal nocturnal haemoglobinuria.

Enhertu received a Breakthrough Therapy Designation from the US FDA3 following ground-breaking results from the DESTINY-Breast03 trial. The Company also announced positive results for Lynparza in prostate cancer, Imfinzi plus tremelimumab in liver cancer, Imfinzi in biliary tract cancer, PT027 in asthma, ALXN1840 in Wilson disease, and AZD7442 in COVID-19 prophylaxis and treatment. Pascal Soriot, Chief Executive Officer, commented: "AstraZeneca’s scientific leadership continues to provide strong revenue growth and exceptional pipeline delivery, with eight positive late-stage readouts across seven medicines since June, including our long acting antibody combination showing promise in both prevention and treatment of COVID-19.

The addition of Alexion furthers our commitment to bring transformative therapies to patients around the world, and I am proud of our colleagues’ ongoing dedication and focus. Our broad portfolio of medicines and diversified geographic exposure provides a robust platform for long-term sustainable growth. Following accelerated investment in upcoming launches after positive data flow, we expect a solid finish to the year and our earnings guidance is unchanged."

Key elements of Total Revenue performance in the year-to-date included:
-An increase in Product Sales of 33% (29% at CER) to $25,043m
-The first contribution from Rare Disease, which generated $1,311m of revenue in the period following completion of the Alexion acquisition on 21 July 2021-Oncology growth of 19% (16% at CER) to $9,744m, CVRM growth of 14% (10% at CER) to $6,028m and R&I growth of 16% (12% at CER) to $4,456m-An increase in Emerging Markets revenue of 33% (28% at CER) to $8,618m. In China, revenue increased 17% (8% CER) to $4,699m in the year to date and by 10% (2% CER) in the quarter. China revenues in the year to date were impacted by pricing pressure associated with NRDL11 and VBP12 programmes.
-Tagrisso’s sequential quarterly performance in China was impacted by inventory phasing and stock compensation relating to NRDL changes in March. In future periods, volume growth from increased patient access is expected to compensate for the lower NRDL price-Revenue in ex-China Emerging Markets increased 60% in the year to date to $3,919m. Excluding vaccine revenue of $1,139m, revenue in ex-China Emerging Markets increased by 13% in the year to date (14% at CER) to $2,780m and by 30% in the quarter to $1,018m, driven by Oncology medicines and Farxiga-In the US, Total Revenue increased by 29% to $8,305m and in Europe by 40% (31% at CER) to $5,178m, including pandemic COVID-19 vaccine revenue of $736m Guidance The Company provides further details on its FY 2021 guidance at CER.

Total revenue excluding the COVID-19 vaccine is expected to grow by a low-twenties percentage, in line with prior guidance. Including vaccine revenues in Q4 2021, revenue is expected to grow by a mid-to-high twenties percentage. Growth in Core EPS13 to $5.05 to $5.40, in line with prior guidance. Prior guidance excluded the revenue and profit impact of sales of the pandemic vaccine. The Company is now expecting to progressively transition the vaccine to modest profitability as new orders are received. COVID-19 vaccine sales in Q4 2021 are expected to be a blend of the original pandemic agreements and new orders, with the large majority coming from pandemic agreements. The limited profit contribution from the vaccine in Q4 2021 is expected to offset costs relating to the Company’s long acting antibody combination (AZD7442), resulting in no change to Core EPS guidance. Core Tax Rate guidance is unchanged at 18-22%.

In general, AstraZeneca continues to recognise the heightened risks and uncertainties from the effects of COVID-19. Variations in performance between quarters can be expected to continue. The Company is unable to provide guidance on a Reported basis because AstraZeneca cannot reliably forecast material elements of the Reported result, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal-settlement provisions.

Please refer to the cautionary statements section regarding forward-looking statements at the end of this announcement. Currency impact If foreign-exchange rates for October to December 2021 were to remain at the average of rates seen in the year to date, it is anticipated that there would be a low single-digit favourable impact on Total Revenue and an immaterial impact on Core EPS versus CER data. The Company’s foreign-exchange rate sensitivity analysis is contained within the operating and financial review.Financial summary-Variances across periods are based on a comparison of the Group’s performance in the year to date and the quarter, including Alexion from 21 July 2021, with the Group’s performance in the comparative prior periods, which do not include Alexion. Pro forma total revenue growth rates have been presented only for Q3 2021 Rare Disease and its constituent medicines, and do not impact any Group totals-Total Revenue, comprising Product Sales and Collaboration Revenue, increased by 32% in the year to date (28% at CER) to $25,406m.

Total Revenue included $2,219m from the pandemic COVID-19 vaccine-Reported Gross Profit14 Margin in the year to date declined eleven percentage points to 68.8%; Core Gross Profit Margin declined six percentage points in the year to date to 74.1%, predominantly reflecting the equitable supply, at no profit to AstraZeneca, of the pandemic COVID-19 vaccine, together with an increasing impact from profit-sharing arrangements (primarily Lynparza and roxadustat) and the impact of the NRDL and VBP programmes in China. These effects were partially offset by the contribution of Alexion from 21 July 2021, a higher proportion of Oncology sales, and increasing patient access in China. Reported Gross Profit Margin was also impacted by $1,044m due to the unwind of the fair value adjustment to Alexion inventories at the date of acquisition.

Variations in gross margin performance between periods can be expected to continue-Reported Total Operating Expense increased in the year to date by 39% (34% at CER) to $17,591m. Core Total Operating Expense increased by 24% (20% at CER) to $13,649m and represented 54% of Total Revenue (YTD 2020: 57%)-Reported R&D Expense increased in the year to date by 67% (63% at CER) to $7,152m including an impairment charge of $1,172m recognised in the quarter on an intangible asset related to the acquisition of Ardea Biosciences, Inc. in 2012, following the decision to discontinue the development of verinurad. Core R&D Expense increased in the year to date by 34% (30% at CER) to $5,591m with increases in both Reported and Core R&D Expense reflecting the Company’s continued investment in its COVID-19 vaccine and AZD7442, investment in several late-stage Oncology trials and the advancement of a number of Phase II clinical development programmes in BioPharmaceuticals-Reported SG&A Expense increased in the year to date by 25% (21% at CER) to $10,117m and includes the increased amortisation of intangible assets related to the Alexion acquisition.

Core SG&A Expense increased by 19% (14% at CER) to $7,736m, reflecting the addition of Alexion SG&A expenses from 21 July 2021, investment in Oncology-medicine launches, the launch of several new BioPharmaceuticals medicines, particularly in the US, AstraZeneca’s further expansion in Emerging Markets, and the existing infrastructure base in China-Reported and Core Other Operating Income and Expense 15 increased in the year to date by 51% (50% at CER) to $1,345m and $1,346m respectively, and included $776m income from the divestment of AstraZeneca’s 26.7% share of Viela Bio, Inc. (Viela) in March 2021-The Reported Operating Profit Margin declined fourteen percentage points (thirteen at CER) to 5.3%, reflecting the aforementioned intangible impairments and other factors. The Core Operating Profit Margin declined two percentage points (one percentage point at CER) in the year to date to 26.0% driven by the aforementioned increase in R&D and SG&A expenses-Reported EPS in the year to date declined 80% (65% at CER) to $0.33. Core EPS increased by 22% (23% at CER) to $3.59. Reported and Core EPS were adversely affected by $0.03 due to the pandemic COVID-19 vaccine

On November 12, 2021 Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company developing transformative, targeted therapeutics to treat life-threatening cancers, reported positive new data from the Phase 1b portion of its open-label Phase 1b/2 trial evaluating batiraxcept (AVB-500) in combination with cabozantinib in patients with clear cell renal cell carcinoma (ccRCC) (Press release, Aravive, NOV 12, 2021, View Source [SID1234595379]). A subset of these data was included in a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting being held November 10-14, 2021.

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"We are encouraged by batiraxcept’s early profile in patients with clear cell renal cell carcinoma," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "The current response rate of batiraxcept in combination with cabozantinib is encouraging. Cabozantinib alone produces response rates between 17-28% in a similar population. In heavily pretreated patients, batiraxcept demonstrates clinical activity across the 15 mg/kg and 20 mg/kg doses with a tolerable safety profile. These results reinforce our confidence in the potential of batiraxcept to improve outcomes across multiple types of cancer by targeting the GAS6/AXL signaling pathway. We look forward to initiating the Phase 2 trial in the fourth quarter of 2021 and building on these promising data."

As of November 9, 2021, the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of batiraxcept 15 mg/kg and 20 mg/kg in combination with cabozantinib in patients with 2L+ ccRCC have been evaluated in 18 patients. Clinical activity across these two doses has been evaluated in 16 patients.

Safety Data:

Analysis of all safety data demonstrates that batiraxcept has been well-tolerated with no dose-limiting toxicities.
There have been no batiraxcept-related serious adverse events reported to date.
There were no batiraxcept-related Grade 4 or 5 adverse events.
3 patients experienced Grade 3 adverse events considered by the investigator as potentially being related to both batiraxcept and cabozantinib.
At the batiraxcept 15 mg/kg dose, 1 patient experienced transient hypertension and 1 patient experienced transient thrombocytopenia. Both events resolved while still receiving batiraxcept.
At the batiraxcept 20 mg/kg dose, 1 patient experienced a thromboembolic event, small bowel obstruction, abdominal pain and vomiting. The bowel obstruction, abdominal pain and vomiting resolved while the patient continued batiraxcept treatment.
All events are known adverse events associated with cabozantinib use.
PK/PD Data:

PK analyses indicate that batiraxcept trough levels were above the minimally efficacious concentration (MEC) of 13.8 mg/L prior to cycle 2 day 1 in the first 10 efficacy-evaluable patients.
Clinical Activity Data:

Best overall response of partial response was observed in 7 of 16 (44%) evaluable patients across both dose levels. 9 of 16 (56%) patients had a best overall response of stable disease. No patients had progressive disease at their first radiological exam.
7 of 16 patients have had at least 16 weeks of follow up (at least two post-baseline radiological exams). 5 of the 7 (71%) patients have confirmed partial responses and 2 of the 7 (29%) patients achieved confirmed stable disease.
88% (14/16) of patients had tumor decrease from baseline.
4 patients had 1 or more target lesions completely disappear. 3 patients were treated with batiraxcept 15 mg/kg and cabozantinib and 1 patient was treated with batiraxcept 20 mg/kg and cabozantinib.
2 patients had target lesions decrease from baseline by more than 76%. 1 patient was treated with batiraxcept 15 mg/kg and 1 patient was treated with batiraxcept 20 mg/kg.
This clinical activity was observed despite cabozantinib dose reductions with median cabozantinib dose intensity of 41 mg (68% of 60 mg prescribed dose).
"The initial Phase 1b data of batiraxcept in combination with cabozantinib are impressive and point toward the role of dual AXL and VEGF inhibition in the treatment of clear cell renal cell carcinoma," said Eric Jonasch, M.D., Professor of Medicine, The University of Texas MD Anderson Cancer Center. "These early signs of clinical activity coupled with a manageable safety profile introduce a potential new therapeutic approach for patients with advanced kidney cancer."

Poster Presentation Details

Title:
A Phase 1b/2 randomized study of AVB-S6-500 in combination with cabozantinib versus cabozantinib alone in patients with advanced clear cell renal cell carcinoma who have received front-line treatment

Presenter:
Reshma Rangwala, M.D., Ph.D., Chief Medical Officer of Aravive

Date:
November 13, 2021

Time:
7:00 a.m. – 8:30 p.m. ET

Location:
Hall E
For additional information, please visit the SITC (Free SITC Whitepaper) 36th Annual Meeting website: View Source

Conference Call Information
Aravive will host a conference call and webcast today, November 12, 2021, at 8:30 a.m. ET to discuss these clinical data. The conference call may be accessed by dialing (877) 423-9813 (domestic) and (201) 689-8573 (international) and referring to conference ID 13724115. A webcast of the conference call will be available in the Investors section of the Aravive website at View Source The archived webcast will be available on Aravive’s website after the conference call.

About the Batiraxcept (AVB-500) Phase 1b/2 ccRCC Trial
The Phase 1b portion of the clinical trial is expected to enroll approximately 25 patients in two dosing parts (15 mg/kg and 20 mg/kg) to evaluate tolerability, PK, PD, and clinical activity of batiraxcept in combination with cabozantinib. The open-label Phase 2 portion of the clinical trial is expected to enroll 55 patients across three parts. Part A is expected to enroll approximately 25 patients and investigate batiraxcept 15 mg/kg in combination with cabozantinib in 2L+ ccRCC patients. Part B is expected to enroll approximately 20 patients and evaluate batiraxcept 15 mg/kg in combination with nivolumab and cabozantinib as a potential front-line treatment for ccRCC. Part C is expected to evaluate batiraxcept 15 mg/kg monotherapy in approximately 10 patients with ccRCC who are not eligible for curative intent therapies.

About Batiraxcept (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.

On November 12, 2021 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated agents that target the underlying mechanisms of cancer, reported financial results for the three months ended September 30, 2021 and provided a corporate update (Press release, Aptose Biosciences, NOV 12, 2021, View Source [SID1234595378]).

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The net loss for the quarter ended September 30, 2021 was $11.3 million ($0.13 per share) compared with $13.2 million ($0.15 per share) for the quarter ended September 30, 2020. The net loss for the nine months ended September 30, 2021 was $41.0 million ($0.46 per share), compared with $40.5 million ($0.51 per share) for the nine months ended September 30, 2020. Total cash and cash equivalents and investments as of September 30, 2021 were $95.1 million. Based on current operations, Aptose expects that cash on hand and available capital provide the Company with sufficient resources to fund all planned Company operations including research and development into early 2023.

"Our recent agreement with Hanmi Pharmaceutical has provided us with a clinical-stage asset in HM43239 (or 239) that already has clinically validated anti-leukemic activity in a diverse array of AML patients, delivering multiple complete responses early in a Phase 1/2 trial thus far," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "As a complement to luxeptinib (Lux), 239 strengthens Aptose’s ability to treat a wider spectrum of AML cancer patients across genotypes; in addition, Lux has the potential to treat a range of patients with relapsed or refractory CLL and other B-cell lymphoid malignancies. Both 239 and Lux are exceptional assets that could propel us to the next level in the field of kinase inhibitors."

Key Corporate Highlights

Exclusive Worldwide License with Hanmi Pharmaceutical for Clinical Candidate HM43239 – Aptose recently entered into an exclusive license agreement with Hanmi Pharmaceutical, a Korean pharmaceutical company, to develop and commercialize HM43239, an oral, highly potent, clinical-stage myeloid kinome inhibitor (MKI), designed to target a distinct constellation of kinases operative in myeloid malignancies, including SYK, FLT3, and others. HM43239 has been well tolerated to date and demonstrated significant genotype-agnostic anti-leukemic activity in an ongoing Phase 1/2 clinical trial, including multiple complete responses (CRs) in patients with relapsed or refractory acute myeloid leukemia (AML). The CRs occurred in AML patients with both FLT3-ITD and FLT3-TKD mutations, including a prior gilteritinib failure patient, and in patients with the wild-type form of FLT3. The AML in these patients harbored additional mutations in TP53, NRAS, NPM1, IDH2, and other important driver genes. More information is available at www.clinicaltrials.gov (NCT03850574).

Luxeptinib Phase 1 a/b Clinical Study in AML and MDS – Luxeptinib, a dual lymphoid and myeloid kinome inhibitor (LKI/MKI), currently is being evaluated in a Phase 1 a/b dose escalation clinical study in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and higher risk MDS. Aptose recently completed the 750 mg dose level, and has escalated to the 900 mg dose cohort. To date, Lux has delivered encouraging anti-leukemic activity in multiple patients, including a durable MRD-negative complete response in a FLT3-ITD AML patient who had relapsed after two allogeneic stem cell transplants, multiple lines of chemotherapy, and prior FLT3 inhibitor therapy. More information is available at www.clinicaltrials.gov (NCT04477291).

Luxeptinib Phase 1 a/b Clinical Study in B-cell Malignancies – Luxeptinib also is being evaluated in a Phase 1 a/b dose escalation clinical study in patients with B-cell malignancies, including chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphomas (NHL), who have failed or are intolerant to two or more lines of established therapies, including drugs such as ibrutinib, rituximab and venetoclax or for whom no other treatment options are available. Thus far, Lux has been well-tolerated in patients treated up to 750 mg BID over multiple cycles and recently has advanced to the 900 mg dose level. Of the evaluable patients at these dose levels, two thirds experienced various reductions of lesion size compared to baseline, demonstrating measurable anti-tumor activity. More information is available at www.clinicaltrials.gov (NCT03893682).

Development of New Formulation for Luxeptinib – In parallel with the dose escalation of the current formulation of luxeptinib in patients with AML and B-cell malignancies, Aptose has made significant progress in the development of a "third generation" (G3) formulation that could deliver up to 30-fold greater exposures per mg of luxeptinib administered. The capsules have been GMP manufactured and passed stability tests; clinical studies are planned for 2022.

Accepted Abstracts for American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting – Aptose has four abstracts, one for each of its ongoing clinical trials, accepted for presentation at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held Saturday, December 11 – Tuesday, December 14, 2021 in Atlanta, GA and virtually. Clinical data for HM43239 has been selected for an oral presentation. In addition, clinical data for luxeptinib and APTO-253 have been accepted for poster presentations.The abstracts accepted for presentation can be viewed online at the ASH (Free ASH Whitepaper) conference website. Aptose also will be holding an investor event during the ASH (Free ASH Whitepaper) timeframe. Details will be forthcoming.

RESULTS OF OPERATIONS

A summary of the results of operations for the three- and nine-month periods ended September 30, 2021 and 2020 is presented below:

The net loss for the three-month period ended September 30, 2021 decreased by $1.9 million to $11.3 million as compared with $13.2 million for the comparable period in 2020. The net loss for the nine-month period ended September 30, 2021 increased by $505 thousand to $41 million as compared with $40.5 million for the comparable period in 2020. Components of the net loss are presented below:

Research and Development
The research and development expenses for the three- and nine-month periods ended September 30, 2021 and 2020 were as follows:

Research and development expenses increased by $199 thousand to $7.7 million for the three-month period ended September 30, 2021 as compared with $7.5 million for the comparative period in 2020. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:

Program costs for luxeptinib increased by approximately $112 thousand, mostly as a result of higher manufacturing costs, including costs to scale up manufacturing and research costs associated with optimizing the formulation.

Program costs for APTO-253 increased by approximately $42 thousand, mostly as a result of higher clinical trial costs related to the APTO-253 Phase 1b trial.

Personnel-related expenses increased by $489 thousand, mostly related to new positions hired to support our clinical trials and manufacturing activities.

Stock-based compensation decreased by approximately $442 thousand in the three months ended September 30, 2021, compared with the three months ended September 30, 2020, mostly related to lower grant date fair value of options in the current period.
Research and development expenses increased by $5.5 million to $25.8 million for the nine-month period ended September 30, 2021 as compared with $20.3 million for the comparative period in 2020. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:

Program costs for luxeptinib increased by approximately $3.1 million, mostly as a result of higher manufacturing costs, including costs to scale up manufacturing and research costs associated with optimizing the formulation and higher costs related to the luxeptinib AML trial, for which we received an IND allowance in June 2020.

Program costs for APTO-253 increased by approximately $516 thousand, mostly as a result of higher manufacturing costs and higher clinical trial costs related to the APTO-253 Phase 1b trial.

Personnel-related expenses increased by $1.6 million, mostly related to new positions hired to support our clinical trials and manufacturing activities.

Stock-based compensation increased by approximately $201 thousand in the nine months ended September 30, 2021, compared with the nine months ended September 30, 2020, mostly related to higher total compensation expense in the current period on options issued in the first half of 2021.
General and Administrative
The general and administrative expenses for the three-month periods and nine-month periods ended September 30, 2021 and 2020 were as follows:

General and administrative expenses for the three-month period ended September 30, 2021 were $3.6 million as compared with $5.8 million for the comparative period in 2020, a decrease of approximately $2.1 million. The decrease was primarily as a result of the following:

General and administrative expenses, other than stock-based compensation and depreciation of equipment, increased by approximately $499 thousand in the three months ended September 30, 2021, primarily as a result of higher insurance costs, higher professional costs and higher regulatory costs offset by lower personnel related costs.

Stock-based compensation decreased by approximately $2.6 million in the three months ended September 30, 2021 as compared with the three months ended September 30, 2020, mostly as a result of a lower number of options granted in the nine month period ended September 30, 2021 as compared with the nine month period ended September 30, 2020, that those options granted in the current period had a lower grant date fair value, and that in the three months ended March 31, 2020, the Company had issued restricted share units (RSUs) that had fully vested by the end of the comparative period. No RSUs were granted in the current period.
General and administrative expenses for the nine-month period ended September 30, 2021 were $15.3 million as compared with $20.7 million for the comparative period, a decrease of approximately $5.4 million. The decrease was primarily a result of the following:

General and administrative expenses, other than share-based compensation and depreciation of equipment, increased by approximately $1.2 million in the nine months ended September 30, 2021, primarily as a result of higher insurance costs, higher professional costs, and higher investor relations advisory costs offset by lower personnel related costs, lower office administrative costs and lower travel expenses.

Stock-based compensation decreased by approximately $6.6 million in the nine months ended September 30, 2021, compared with the nine months ended September 30, 2020. Stock-based compensation decreased by approximately $8.3 million, mostly as a result of a lower number of options granted in the nine-month period ended September 30, 2021 as compared with the options granted in the nine-month period ended September 30, 2020, that those options granted in the current period had a lower grant date fair value, and that in the comparative period the Company had issued restricted share units (RSUs) that had fully vested by the end of the comparative period. This decrease was offset by increased compensation of approximately $1.7 million, mostly related to the modification of option agreements of one officer as part of a separation and release agreement. Vested options of 1,679,169 with exercise prices ranging from $1.03 to $7.44 were allowed to continue to be exercisable for an additional twelve-month period, and also 504,833 options that would have expired unvested were allowed to continue to vest for a twelve-month period. As there was no service requirement, the Company recorded $945 thousand and $663 thousand additional compensation in the nine-month period related to these modifications for the vested and unvested options, respectively.
COVID-19 did not have a significant impact on our results of operations for the nine-month period ended September 30, 2021. We have not experienced and do not foresee material delays to the enrollment of patients or timelines for the luxeptinib and HM43239 trials due to the variety of clinical sites that are actively recruiting for these trial. APTO-253, which is administered intravenously, requires the need for hospital / clinical site resources to assist and monitor patients during each infusion and based on the current conditions caused by COVID-19, future enrollment of patients on this trial is likely to be negatively impacted. As of the date of this report, we have not experienced material delays in the manufacturing of luxeptinib, HM43239, or APTO-253 directly related to COVID-19. Should our manufacturers be required to shut down their facilities due to COVID-19 for an extended period of time, our trials may be negatively impacted.

Conference Call and Webcast

Aptose will host a conference call to discuss results for the quarter ended September 30, 2021 today, Thursday, November 11, 2021 at 5:00 PM ET. Participants can access the conference call by dialing 1-844-882-7834 (North American toll-free number) and 1-574-990-9707 (international/toll number) and using conference ID # 5675957. The conference call can be accessed here and will also be available through a link on the Investor Relations section of Aptose’s website at View Source An archived version of the webcast along with a transcript will be available on the Company’s website for 30 days.

The press release, the financial statements and the management’s discussion and analysis for the quarter ended September 30, 2021 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml.

On November 12, 2021 Chemomab Therapeutics, Ltd. (Nasdaq: CMMB) (Chemomab), a clinical-stage biotech company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, reported financial and operating results for the third quarter ended September 30, 2021, and provided a corporate update (Press release, Anchiano Therapeutics, NOV 12, 2021, View Source [SID1234595376]).

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Recent Highlights and Upcoming Events

Presenting a poster at The Liver Meeting 2021, being held November 12-15, 2021, confirming that CCL24, the target for Chemomab’s first-in-class monoclonal antibody CM-101, induces the liver inflammation and fibrosis seen in primary cholangitis sclerosis (PSC) and other diseases. The preclinical data also show CM-101 can interfere with the core fibrotic and inflammatory mechanisms driving the pathophysiology of PSC, providing further evidence that CM-101 potentially could be an effective treatment for PSC and for other fibrotic and inflammatory diseases.
Named Donald Marvin as Chief Financial Officer, Executive Vice President and Chief Operating Officer. Mr. Marvin is a seasoned biotech executive with over 35 years of experience in corporate finance and fundraising, strategy, corporate development, mergers and acquisitions, and operations in both public and private life sciences companies.
Hosted Webinar featuring KOL Dr. Dinesh Khanna, who discussed the systemic sclerosis (SSc) treatment landscape, high unmet medical need for more holistic therapies, and how use of composite endpoints could facilitate the clinical development of disease-modifying therapies. Chemomab researchers highlighted the extensive data supporting CM-101’s anti-fibrotic and anti-inflammatory effects and unveiled the design of the upcoming Phase 2 clinical trial in SSc, expected to begin in early 2022.
Presented data on CM-101 at the Fifth Annual Antifibrotic Drug Development Summit highlighting the role of CCL24 as a key target for fibrosis and inflammation, including data describing the preclinical validation of CCL24, the development process for CM-101 from discovery to clinical trials, and optimization of the clinical trial design using patient samples.
Announced collaboration with Leeds University to further elucidate the role of CCL24 in the vascular damage associated with systemic sclerosis. Led by Professor Francesco Del Galdo, Head of the Scleroderma Program at the Leeds Musculoskeletal Biomedical Research Centre, the collaboration seeks to provide additional insights into the mechanisms underlying CCL24-associated vascular damage. It also could uncover additional application opportunities for CM-101.
Appointed Dale Pfost, PhD as Chief Executive Officer. The addition of Dr. Pfost, who brings more than 30 years of diverse experience as a life sciences senior executive, entrepreneur and venture investor, reflects a planned strategic expansion of the Chemomab senior management team. Dr. Adi Mor will continue as Chief Scientific Officer. A shareholder vote confirmed Dr. Pfost’s appointment.
"In my first weeks as CEO, I continue to be impressed with the diligence and overall excellence of the Chemomab team, and I am delighted to be part of this exceptional organization," said Dale Pfost, PhD, CEO of Chemomab. "With two established Phase 2 programs underway targeting conditions with high unmet medical need and a third Phase 2 program in systemic sclerosis, the most lethal of the rheumatic diseases, expected to begin soon, we have a great deal to look forward to in the coming year. We anticipate readouts from the ongoing Phase 2 clinical trials in PSC and liver fibrosis in 2022, and we are hopeful that the results will confirm the potential of CM-101, our ‘pipeline in a product’, to treat multiple severe fibrotic and inflammatory diseases. With targeted additions to our senior team, including life sciences veteran CFO and COO Don Marvin now onboard, we believe we are well positioned to continue advancing our pipeline while also assessing selected strategic opportunities to further grow the business."

Program Updates:

CM-101 Phase 2a SPRING trial in primary sclerosing cholangitis continues to enroll patients. The SPRING study is a multi-center, randomized, double-blind, placebo-controlled, multiple dose trial designed to evaluate CM-101’s anti-fibrotic effects in PSC patients, as well as its safety, pharmacokinetics and pharmacodynamics. In response to challenges related to the evolving COVID-19 pandemic, Chemomab has expanded the number of trial sites beyond the UK and Israel to include additional territories with significant recruitment potential. The company anticipates it will report data from this trial in the second half of 2022.

CM-101 Phase 2a SPLASH trial in liver fibrosis remains on track, with data expected in the first half of 2022. The SPLASH study is a multi-center, randomized, double-blind, placebo-controlled, multiple dose study designed to assess the mechanism of action, safety, pharmacokinetics and pharmacodynamic effects, as well as the anti-fibrotic effects of a subcutaneous formulation of CM-101 in NASH patients with fibrosis stage F2-F3.

CM-101 Phase 2 clinical trial for the treatment of systemic sclerosis is scheduled to begin early in 2022. Preparations for initiation of the Phase 2 trial in systemic sclerosis are continuing. The trial will be a multi-center, randomized, double-blind, placebo-controlled study with two treatment arms designed to assess CM-101 as a treatment for patients with diffuse systemic sclerosis. The study will enroll 220 patients who will be equally distributed between the two treatment arms. Participating patients will be treated for a period of 45 weeks. The study will include 100 participating sites in the US, EU and Israel.

Third Quarter 2021 Financial Highlights

Cash, cash equivalents (including bank deposits) as of September 30, 2021, were $64.3 million compared to $11.7 million at December 31, 2020. The existing cash position is expected to fund the Company’s current operating plan until mid-2023.
During the quarter ended September 30, 2021, Chemomab did not sell shares under the Company’s ATM program.
Research and Development expenses for the three months ended September 30, 2021, were $1.5 million, compared to $1.0 million for the three months ended September 30, 2020. The increase of about $0.5 million was primarily related to increases in expenses related to preclinical and clinical activities. R&D expenses are expected to substantially increase over the next several quarters as Chemomab continues to advance its clinical programs.
General and administrative expenses were $1.4 million for the three months ended September 30, 2021, compared to $0.2 million for the three months ended September 30, 2020. The increase of about $1.2 million is primarily derived from expenses associated with public company operations, as well as about $370,000 in non-cash expenses associated with share-based compensation.
Net loss for the three months ended September 30, 2021, was $3.0 million or ($0.01) per basic and diluted ordinary share, compared to $1.2 million, or ($0.01) per basic and diluted ordinary share, for the prior year period.
For further details on the Company’s financial results, including the results for the nine and three months ended September 30, 2021, refer to the Form 10-Q filed with the SEC.