On November 7, 2021 Everest Medicines (HKEX 1952.HK, "Everest" or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asia, reported that its board directors resolved to increase the share repurchase program by up to HK$100 million (Press release, Everest Medicines, NOV 7, 2021, View Source [SID1234594665]).

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The Company has repurchased 1,615,500 ordinary shares equivalent to approximately HK$71 million in the open market in the period from October 4, 2021 to November 5, 2021 under the HK$100 million share repurchase program announced on and effective from August 30, 2021. In addition to the HK$100m share repurchase program resolved by the board on August 30, 2021, the board further resolved to repurchase an additional up to HK$100 million of its ordinary shares from the open market from time to time on November 5, 2021.

The board believes that an additional share repurchase program in the present conditions demonstrate the Company’s confidence in its own business outlook and would, ultimately, benefit the Company and create value to the shareholders. The board also believes that the current financial resources of the Company are sufficient to implement the share repurchase while maintaining a solid financial position.

The Company will conduct any share repurchase in compliance with the memorandum and articles of association of the Company, the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited, the Codes on Takeovers and Mergers and Share Buybacks, the Companies Law of the Cayman Islands and all applicable laws and regulations to which the Company is subject to.

On November 6, 2021 Philogen reported its attendance at the Festival of Biologics Basel on November 10, 2021 (Press release, Philogen, NOV 6, 2021, View Source [SID1234594678])

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Lisa Nadal, 3-year PhD student at Philogen, is giving a lecture entitled "A novel IL12-based immunocytokine targeting Fibroblast Activation Protein (FAP) for the treatment of cancer"

Roberto De Luca, Head of Antibody Therapeutics at Philogen, is giving a lecture entitled "Tripokin: tumor targeted delivery of IL2 potentiated by TNF"

Samuele Cazzamalli, Head of Small Molecule Therapeutics at Philogen, is giving a lecture entitled "Pan-tumoral Small Molecule-Drug Conjugates targeting Fibroblast Activation Protein in solid lesions"

Dario Neri, co-founder, CEO and CSO, is giving a lecture entitled "Antibody-cytokine fusions directed against splice variants of fibronectin for the therapy of disseminated cancer: from discovery to Phase III clinical trials"

On November 5, 2021Sierra Oncology, Inc. (SRRA), a late-stage biopharmaceutical company with a mission to deliver targeted therapies that treat rare forms of cancer, reported its financial and operating results for the third quarter ended September 30, 2021 (Press release, Sierra Oncology, NOV 5, 2021, View Source [SID1234594588])."The past several months have been quite productive for Sierra with the addition of SRA515 to our pipeline and preparing for momelotinib pivotal data," said Stephen Dilly, MBBS, PhD, President and Chief Executive Officer of Sierra Oncology. "We remain focused on the completion of the MOMENTUM study and look forward to sharing topline results by February next year."

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Key Business Highlights

The pivotal, Phase 3 MOMENTUM study remains on track to report topline data by February 2022. Assuming positive results, the company plans to submit a New Drug Application with the US Food & Drug Administration in the second quarter of 2022.
An exclusive global in-licensing agreement for SRA515 (formerly AZD5153), a potent and selective BRD4 BET inhibitor with a novel bivalent binding mode, was announced on August 5. The initiation of a Phase 2 study examining momelotinib in combination with SRA515 for the treatment of myelofibrosis is planned for the first half of 2022. We continue to evaluate additional studies and may initiate other new trials for SRA515 and SRA737 in 2022.
Sierra raised $37.0 million in gross proceeds through the use of its at-the-market (ATM) offering during the third quarter of 2021 and ended the quarter with $97.1 million in cash and cash equivalents. Subsequent to the close of the third quarter, the company has raised an additional $12.6 million in gross proceeds via the ATM. The company also has the potential to obtain up to $33.3 million in cash from Series B warrants that must be exercised within 75 days of the announcement of MOMENTUM topline data.
On November 4, the company announced the acceptance of a momelotinib abstract for poster presentation at the 2021 Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper). The poster, "Baseline Serum Ferritin Differentially Predicts W24 Transfusion Independence Response for Momelotinib and Ruxolitinib in Patients with Myelofibrosis" will be presented on Monday, December 13, 2021, from 6:00 – 8:00 pm ET, Georgia World Congress Center, Hall B5. The abstract has been published online View Source and a pre-recorded presentation of the poster will be made available for participants attending virtually.
Third Quarter 2021 Financial Results (all amounts reported in U.S. currency)

Research and development expenses were $21.6 million for the three months ended September 30, 2021 compared with $10.4 million for the three months ended September 30, 2020. The increase primarily related to an upfront cash payment of $8.0 million that was made to AstraZeneca for the exclusive global license of SRA515. Also attributing to the increase was a $2.2 million increase in personnel-related and allocated overhead costs, of which $0.6 million pertained to an increase in non-cash stock-based compensation, a $1.0 million increase in third-party manufacturing costs for momelotinib, and a $0.3 million increase in other research and support costs. These increases were partially offset by a $0.3 million decrease in clinical trial and development costs for momelotinib. Research and development expenses included non-cash stock-based compensation of $1.8 million and $1.2 million for the three months ended September 30, 2021 and 2020, respectively.

Research and development expenses were $49.7 million for the nine months ended September 30, 2021, compared with $32.2 million for the nine months ended September 30, 2020. The increase was due to an upfront cash payment of $8.0 million that was made to AstraZeneca for the exclusive global license of SRA515, a $5.8 million increase in personnel-related and allocated overhead costs, of which $2.6 million pertained to an increase in non-cash stock-based compensation, and costs for momelotinib including a $2.8 million increase in clinical trial and development costs and a $2.4 million increase in third-party manufacturing costs. These increases were partially offset by a $1.5 million non-cash charge incurred in 2020 to recognize the change in fair value of an obligation to issue securities to Gilead until the issuance of the securities in January 2020. Research and development expenses included non-cash stock-based compensation of $5.3 million and $2.7 million for the nine months ended September 30, 2021 and 2020, respectively.

General and administrative expenses were $7.0 million for the three months ended September 30, 2021, compared to $4.1 million for the three months ended September 30, 2020. The increase was due to a $1.7 million increase in personnel-related and allocated overhead costs, of which $0.6 million pertained to an increase in non-cash stock-based compensation, and a $1.2 million increase in professional fees primarily relating to pre-commercial costs for momelotinib. General and administrative expenses included non-cash stock-based compensation of $1.5 million and $0.9 million for the three months ended September 30, 2021 and 2020, respectively.

General and administrative expenses were $19.3 million for the nine months ended September 30, 2021, compared to $14.9 million for the nine months ended September 30, 2020. The increase was due to a $2.7 million increase in personnel-related and allocated overhead costs, of which $0.2 million pertained to an increase in non-cash stock-based compensation, and an increase of $1.7 million in professional fees primarily relating to pre-commercial costs for momelotinib. General and administrative expenses included non-cash stock-based compensation of $4.2 million and $4.0 million nine months ended September 30, 2021 and 2020, respectively.

Total other expense (income), net was $0.1 million of total other expense, net for the nine months ended September 30, 2021, compared to $15.7 million of total other expense, net for the nine months ended September 30, 2020. The difference was primarily attributable to a non-cash charge of $16.2 million incurred during the nine months ended September 30, 2020 related to the change in fair value of warrant liabilities until the reclassification to equity in January 2020.

For the three months ended September 30, 2021, Sierra incurred a Generally Accepted Accounting Principles (GAAP) net loss of $28.6 million compared to a GAAP net loss of $14.5 million for the three months ended September 30, 2020. For the nine months ended September 30, 2021 Sierra incurred a GAAP net loss of $69.2 million compared to a GAAP net loss of $62.9 million for the nine months ended September 30, 2020. The GAAP net loss for the three and nine months ended September 30, 2021 includes an upfront cash payment of $8.0 million that was made to AstraZeneca for the exclusive global license of SRA515. The GAAP net loss for the nine months ended September 30, 2020 includes a non-cash charge of $16.2 million related to the change in fair value of warrant liabilities included in total other expense (income), net and a $1.5 million non-cash charge pertaining to the obligation to issue securities to Gilead included in research and development expenses as mentioned above.

Non-GAAP adjusted net loss was $25.4 million for the three months ended September 30, 2021, compared with a non-GAAP adjusted net loss of $12.4 million for the three months ended September 30, 2020. Non-GAAP adjusted net loss for the three months ended September 30, 2021 and 2020 excludes expenses related to stock-based compensation. For the nine months ended September 30, 2021, Sierra incurred a non-GAAP adjusted net loss of $59.8 million compared to a non-GAAP adjusted net loss of $38.5 million for the nine months ended September 30, 2020. Non-GAAP adjusted net loss for the nine months ended September 30, 2021 excludes expenses related to stock-based compensation. Non-GAAP adjusted net loss for the nine months ended September 30, 2020 excludes expenses related to the change in fair value of warrant liabilities, the change in fair value of the securities issuance obligation, and stock-based compensation. See "Non-GAAP Financial Measures" and "Reconciliation of GAAP to Non-GAAP Financial Measures" below for a reconciliation of this GAAP measure to non-GAAP financial measure.

Cash and cash equivalents totaled $97.1 million as of September 30, 2021, compared to $104.1 million as of December 31, 2020.

As of September 30, 2021, there were 14,498,953 total shares of common stock outstanding and warrants to purchase 11,040,894 shares of common stock, with an exercise price equal to $13.20 per share. There were 4,880,267 shares issuable upon exercise of stock options and an additional warrant to purchase 1,839 shares.

On November 5, 2021 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported that it plans to host a conference call on Tuesday, November 9, 2021, at 8:30 a.m. ET to discuss its financial results for the quarter ended September 30, 2021 and provide a business update (Press release, Selecta Biosciences, NOV 5, 2021, https://selectabio.gcs-web.com/news-releases/news-release-details/selecta-biosciences-host-conference-call-and-webcast-discuss-6 [SID1234594589]).

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Individuals may participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10147803. Investors and the public can access the live and archived webcast of this call and a copy of the presentation via the Investors & Media section of the company’s website, www.selectabio.com.

On November 5, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported its financial results and development highlights for the quarter ended September 30, 2021 (Press release, Oncolytics Biotech, NOV 5, 2021, View Source [SID1234594604]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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"Over the past few months, we achieved key milestones that have advanced pelareorep’s development programs and further highlighted the advantages of its broadly applicable mechanism of action," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "These milestones include the reporting of new clinical biomarker data from our AWARE-1 breast cancer study, which we are pleased to be announcing today. These data further demonstrate pelareorep’s immunotherapeutic effects and its ability to synergize with checkpoint inhibition. It also indicates that changes in peripheral blood T cell populations may be predictive of patient response. This exciting finding could improve our chances of success in subsequent studies by allowing for early identification of patients most likely to benefit from pelareorep therapy. We are evaluating this hypothesis as part of our BRACELET-1 breast cancer trial, which is assessing the safety, efficacy, and pharmacodynamic effects of pelareorep with and without checkpoint inhibition to support the advancement of our lead program to a registrational study."

Dr. Coffey continued, "Beyond our lead program, we also advanced our collaboration with Roche and AIO with the initiation of dosing in our phase 1/2 GOBLET trial. This trial addresses a pressing unmet need in gastrointestinal cancer by leveraging pelareorep’s immunotherapeutic effects to overcome checkpoint inhibitor resistance and then increase the proportion of patients responding to checkpoint inhibition therapies. Looking forward, we will continue to strategically leverage collaborations and partnerships to drive pelareorep’s development as an enabling technology for various immuno-oncology agents across multiple indications with high unmet needs. We believe this will allow us to maximally benefit from pelareorep’s value-creating potential while maintaining focus on our lead breast cancer program."

Third Quarter and Subsequent Highlights

Breast Cancer Program

AWARE-1 data indicate that changes in peripheral blood T cell populations may be a predictive biomarker of pelareorep therapy

Additional analyses from AWARE-1’s first two cohorts being announced today focus on changes in the peripheral blood and tumors’ T cell populations of HR+/HER2- early-stage breast cancer patients following treatment with pelareorep and letrozole without (cohort 1) or with (cohort 2) the PD-L1 inhibitor atezolizumab. These changes were compared to assessments of CelTIL score (a measure of tumor cellularity and inflammation) and tumor-infiltrating CD8+ T cells, two metrics that are associated with favorable clinical outcomes. Highlights from the analyses using Spearman’s Rank-Order Correlation not adjusted for multiplicity are shown below:

Pooled analysis across cohorts showed:
A statistically significant decrease in peripheral blood T cell diversity post-treatment, explained by the expansion and generation of new middle frequency anti-viral and anti-tumor T cell clones.
A statistically significant association between pre- vs. post-treatment decreases in peripheral blood T cell diversity and increased post-treatment CelTIL score.
A statistically significant association between increased peripheral blood T cell fraction pre-treatment and tumor-infiltrating CD8+ T cells post-treatment.
Comparative analysis of cohort 1 vs. cohort 2 showed:
The addition of atezolizumab enhanced pelareorep’s ability to generate and expand new anti-viral and anti-tumor T cell clones.
A greater decrease in pre- vs. post-treatment changes in peripheral blood T cell diversity in cohort 2 compared to cohort 1.
A numerical association between decreased post-treatment T cell diversity in the peripheral blood and pre- vs. post-treatment increases in tumor-infiltrating CD8+ T cells in cohort 1. This association reached statistical significance in cohort 2 with the addition of atezolizumab.
Collectively, these analyses further demonstrate pelareorep’s immunotherapeutic mechanism of action and its ability to synergize with checkpoint inhibitors such as atezolizumab. They also suggest that changes in peripheral blood T cell populations are predictive of response to pelareorep therapy and could potentially serve as the basis for a blood-based biomarker to inform the design of subsequent studies.

Oncolytics has completed its planned analyses of AWARE-1’s first two cohorts, which enrolled patients with HR+/HER2- breast cancer. Evaluation of these cohorts was the core objective of AWARE-1, as HR+/HER2- is the breast cancer subtype Oncolytics intends to examine in a future registrational study. Following the completion of these cohorts, Oncolytics amended the protocol of the trial so that all remaining cohorts focus exclusively on patients with the HER2+ breast cancer subtype. Together with AWARE-1’s first two cohorts and the ongoing IRENE trial in triple-negative breast cancer, these cohorts will facilitate the evaluation of pelareorep in all breast cancer subtypes.

Partner Adlai Nortye dosed first patient in Chinese bridging trial evaluating pelareorep-paclitaxel combination treatment in breast cancer

The bridging clinical trial is evaluating the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer. Results are expected to allow Adlai Nortye to include data from Oncolytics’ North American IND-213 and BRACELET-1 trials in a future submission to Chinese regulators. This may accelerate pelareorep’s clinical development path in China, which has a rapidly growing pharmaceutical market that is currently the second largest in the world.

Gastrointestinal Cancers Program

Dosed first patient in the phase 1/2 GOBLET trial in collaboration with Roche and AIO

GOBLET is a phase 1/2 multi-center trial designed to evaluate the use of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal, and advanced anal cancers. The trial is being managed by AIO, a leading academic cooperative medical oncology group based in Germany. In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, the trial also seeks to validate CEACAM6 and T cell clonality as predictive biomarkers, which may improve the patient selection process in future registration studies and increase their likelihood of success. The trial builds off previously reported phase 2 data demonstrating clinical proof-of-concept for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer (link to PR, link to poster), as well as prior early clinical data showing that pelareorep-based combinations stimulated an adaptive immune response and led to a greater than 90% clinical benefit rate in KRAS mutated colorectal cancer patients (link to PR, link to study), and a greater than 80% increase in progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression (link to PR, link to poster).

Additional Immunotherapeutic Combinations and Opportunities

Announced preclinical data demonstrating the synergistic immunotherapeutic effects of pelareorep combined with radiotherapy

Preclinical data presented in a poster at The International Conference on Immunotherapy Radiotherapy Combinations showed that combination treatment with pelareorep and radiotherapy promoted the tumor infiltration of anti-cancer T cells and prolonged survival in a murine cancer model. Increased infiltration of anti-cancer T cells was observed both in tumors exposed to local treatment with radiation and pelareorep, and in tumors located away from the treatment site. Collectively, these data are indicative of the synergistic immunotherapeutic effects of the pelareorep-radiotherapy combination (link to PR, link to poster).

Financial Highlights

As of September 30, 2021, the Company reported $48.1 million in cash and cash equivalents.
Operating expense for the third quarter of 2021 was $2.9 million, compared to $2.5 million in the third quarter of 2020.
R&D expense for the third quarter of 2021 was $3.3 million, compared to $3.9 million in the third quarter of 2020.
Net cash used in operating activities for the third quarter of 2021 was $3.7 million, compared to $6.1 million for the third quarter of 2020.
The net loss for the third quarter of 2021 was $4.9 million, compared to a net loss of $6.7 million in the third quarter of 2020. The basic and diluted loss per share was $0.09 in the third quarter of 2021, compared to a basic and diluted loss per share of $0.16 in the third quarter of 2020.
Anticipated Milestones and Catalysts

Completion of enrollment in phase 2 BRACELET-1 metastatic breast cancer study: Q4 2021/Q1 2022
Interim safety update from phase 2 IRENE study in triple-negative breast cancer: Q4 2021
Multiple myeloma study data: Q4 2021
Oncolytics expects to provide updates on the timing of the following milestones:

Interim safety update from BRACELET-1 metastatic breast cancer study
Phase 2 BRACELET-1 metastatic breast cancer study: final data
Webcast and Conference Call
Management will host a conference call for analysts and institutional investors at 8:00 a.m. ET today, November 5, 2021. To access the call, please dial (888) 664-6383 (North America) or (416) 764-8650 (International) and, if needed, provide confirmation number 7285-9440. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 859-440#.