On November 10, 2021 ChemoCentryx, Inc., (Nasdaq: CCXI), reported that Thomas J. Schall, Ph.D., President and Chief Executive Officer, will participate in two upcoming investor conferences (Press release, ChemoCentryx, NOV 10, 2021, View Source [SID1234595270]):

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Stifel 2021 Virtual Healthcare Conference
Fireside Chat Wednesday, November 17 at 2:00 p.m. Eastern Time
Piper Sandler 33rd Annual Virtual Healthcare Conference
On-demand presentation available beginning Monday, November 22 at 10:00 a.m. Eastern Time
A live audio webcast of the Stifel fireside chat, as well as the on-demand Piper Sandler presentation can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. Replays of both the Stifel and Piper Sandler presentations will be available on the Company’s website for two weeks following the respective presentation dates.

On November 10, 2021 Werewolf Therapeutics, Inc. (the "Company" or "Werewolf") (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer, reported financial results for the quarter ended September 30, 2021 (Press release, Werewolf Therapeutics, NOV 10, 2021, View Source [SID1234595053]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Werewolf Therapeutics continues to make significant progress advancing and executing across our pipeline and we are on track to file INDs for our two lead INDUKINE product candidates, WTX-124 and WTX-330, in the first half of 2022," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "We have also achieved several important corporate milestones, including the announcement of our clinical trial collaboration and supply agreement with Merck to evaluate WTX-124 in combination with KEYTRUDA."

Merck Collaboration: In August 2021, Werewolf announced its entry into a clinical trial collaboration agreement with Merck, known as MSD outside the United States and Canada, to evaluate WTX-124, a systemically-delivered, conditionally activated Interleukin-2 (IL-2) INDUKINE product candidate, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy. The planned clinical trial will be conducted by Werewolf and is designed to evaluate the safety and preliminary efficacy of WTX-124 as a monotherapy and in combination with KEYTRUDA in patients with solid tumors.

Expanded the Board of Directors: In October 2021, Werewolf appointed Meeta Chatterjee, Ph.D., as a member of the Board of Directors. Dr. Chatterjee brings over 30 years of broad strategic and operational experience in pharmaceutical research and development, mergers and acquisition evaluation, in-licensing, and externalization activities.

Upcoming preclinical presentations at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) being held November 10-14, 2021 in Washington, DC: Werewolf will present posters on its lead programs WTX-124 (Poster #718), WTX-330 (Poster #715) and WTX-613 (Poster #723) describing the design and preclinical evaluation of Werewolf’s IL-2, IL-12 and IFN-a INDUKINE molecules.

Third Quarter 2021 Financial Highlights

Cash position: As of September 30, 2021, cash and cash equivalents were $170.4 million, compared to $92.6 million as of December 31, 2020. The increase was primarily due to the receipt of $109.2 million in net proceeds from the initial public offering completed in May 2021, offset by operating expenses incurred during the period. Given the strength of its balance sheet, Werewolf expects its existing cash and cash equivalents to enable the funding of its operating expenses and capital expenditure requirements through at least the second quarter of 2023.

Research and development expenses: Research and development expenses were $9.8 million for the third quarter of 2021, compared to $4.8 million for the same period in 2020. The increase in research and development expenses was primarily due to increased manufacturing, contract research organization, and personnel expenses incurred to advance the Company’s product candidates WTX-124, WTX-330 and WTX-613 and expand research and development activities.

General and administrative expenses: General and administrative expenses were $4.0 million for the third quarter of 2021, compared to $1.2 million for the same period in 2020. The increase in general and administrative expenses was primarily due to increased personnel, professional services, and other operating costs attributable to operating as a public company.

Net loss: Net loss was $13.8 million for the third quarter of 2021, compared to $6.1 million for the same period in 2020.

On November 10, 2021 AUSTIN, Texas, Nov. 10, 2021 (GLOBE NEWSWIRE) — Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, reported financial results for the third quarter ended September 30, 2021 (Press release, Pain Therapeutics, NOV 10, 2021, View Source [SID1234595069]). Net loss for the third quarter ended September 30, 2021, was $9.6 million, or $0.24 per share, compared to a net loss of $1.4 million, or $0.06 per share, for the same period in 2020. Net cash used in operations was $22.2 million during the first nine months of 2021. Net cash use for operations for full-year 2021 is expected to be approximately $25 to $30 million, up from previous guidance of $20 to $25 million due to a significant prepayment made to a contract research organization for our Phase 3 clinical program with simufilam. An additional $22.0 million was used during the third quarter of 2021 for an all-cash purchase of an office complex in Austin, Texas, which will serve as the Company’s future corporate headquarters. Cash and cash equivalents were $241.5 million as of September 30, 2021, with no debt.

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Financial Highlights for Third Quarter 2021

At September 30, 2021, cash and cash equivalents were $241.5 million, compared to $93.5 million at December 31, 2020, with no debt.

Net cash used in operations during the nine months ended September 30, 2021 was $22.2 million, net of reimbursements received from the National Institutes of Health (NIH) grant awards. An additional $22.0 million was used during the third quarter of 2021 for the purchase of an office complex in Austin, Texas, which will serve as the Company’s future corporate headquarters.

Net cash use for operations for full year 2021 is expected to be approximately $25 to $30 million, up from previous guidance of $20 to $25 million due to a prepayment made to a contract research organization for Phase 3 clinical program with simufilam. Net cash use in 2021 is expected to be driven by prepayments made for clinical trial management services for Phase 3 studies, higher headcount and personnel expenses, manufacturing costs around large-scale drug supply, and professional services expenses related to clinical programs.

R&D expenses were $8.0 million compared to $0.4 million for the same period in 2020. This increase was due primarily to costs related to manufacture of clinical trial supplies for and the initiation of a Phase 3 clinical program with simufilam, costs of an on-going open-label study in simufilam, as well as increased personnel expenses. These increases were partially offset by an increase in grant funding received from NIH and recorded as a reduction in research and development expenses.

Research grant funding reimbursements of $2.0 million were received from NIH and recorded as a reduction in research and development (R&D) expenses. This compared to $1.0 million of NIH grant receipts received for the same quarter in 2020.

General and administrative (G&A) expenses were $1.7 million compared to $1.0 million for the same period in 2020. This increase was due primarily to higher legal fees and insurance costs as well as depreciation and amortization for an office complex in Austin, Texas, purchased in third quarter 2021 as compared to the prior year.

On November 10, 2021 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported financial results for the third quarter ended September 30, 2021 (Press release, Nkarta, NOV 10, 2021, View Source [SID1234595085]).

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"We are on track to achieve key data milestones for our two co-lead programs in 2022 with the recently announced dosing of patients in our clinical trial of NKX019 and further progress in our first-in-human clinical trial of NKX101," said Paul J. Hastings, President and Chief Executive Officer of Nkarta. "We continue to be excited about the early advancements we are making in our collaboration with CRISPR Therapeutics on CD70 engineered CAR NK cell and NK plus T cell candidates, and we look forward to sharing updates on potential clinical applications of multiple platform enhancements during the SITC (Free SITC Whitepaper) annual meeting."

RECENT UPDATES

NKX101

In October 2021, Nkarta updated guidance to the first half of 2022 for when it expects to announce initial clinical data from its ongoing Phase 1 clinical trial of NKX101 in patients with relapsed/refractory acute myeloid leukemia (AML) and higher risk myelodysplastic syndromes (MDS).
NKX019

In October 2021, Nkarta announced the dosing of the first patients in the Phase 1 clinical trial evaluating NKX019 in CD19+ advanced B cell malignancies. Initial data are expected in 2022.
Manufacturing

Nkarta is producing the clinical supply of NKX019 at its recently commissioned in-house cGMP clinical manufacturing facility in South San Francisco, California.
Nkarta entered a lease agreement to establish a new 88,000 square foot combined manufacturing facility and company headquarters. Once operational, the manufacturing facility will increase Nkarta’s manufacturing footprint with capacity to produce materials for potential pivotal trials and commercial launch of Nkarta’s engineered NK cell therapy products.
Pipeline and Platform

Nkarta is announcing updates on multiple platform and pipeline enhancements at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36TH Annual Meeting and Pre-Conference Program (SITC 2021) November 10 – 13, 2021. Preclinical data on CRISPR/Cas9 genome engineering and CD70 chimeric antigen receptor (CAR) targeting are being jointly presented with CRISPR Therapeutics. In addition, Nkarta will be presenting data on donor selection in next generation NK cell development programs and novel methods for scaling the expansion of engineered NK cells.
THIRD QUARTER 2021 FINANCIAL HIGHLIGHTS

Cash and Cash Equivalents: As of September 30, 2021, Nkarta had cash, cash equivalents, restricted cash and short-term investments of $259.8 million.

R&D Expenses: Research and development expenses were $16.6 million for the third quarter of 2021. Non-cash share-based compensation expense included in R&D expense was $1.7 million for the third quarter of 2021.

G&A Expenses: General and administrative expenses were $5.8 million for the third quarter of 2021. Non-cash share-based compensation expense included in G&A expense was $2.0 million for the third quarter of 2021.

Net Loss. Net loss was $22.4 million, or $0.68 per basic and diluted share, for the third quarter of 2021.
FINANCIAL GUIDANCE

Nkarta expects its current cash and cash equivalents will be sufficient to fund its current operating plan into at least the second half of 2023.
About NKX101
NKX101 is an investigational, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy donors and engineered with membrane-bound IL-15 and a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely expressed on cancer cells. By engineering NKX101 with the proprietary NKG2D-based CAR, the ability of NK cells to recognize and kill tumor cells in pre-clinical models is increased significantly compared to non-engineered NK cells. The addition of membrane-bound interleukin-15 (IL-15), a proprietary version of a cytokine for activating NK cell growth, has been shown in pre-clinical models to enhance the proliferation, persistence and sustained activity of NK cells. To learn more about the NKX101 clinical trial in adults with AML or MDS, please visit ClinicalTrials.gov.

About NKX019
NKX019 is an investigational, allogeneic, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed CAR for enhanced tumor cell targeting and a proprietary, membrane-bound form of IL-15 for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal and malignant B cells, and it is a validated target for B cell cancer therapies. To learn more about the clinical trial of NKX019 in advanced B cell malignancies, please visit ClinicalTrials.gov.

On November 10, 2021 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the third quarter ended September 30, 2021 (Press release, VolitionRX, NOV 10, 2021, View Source [SID1234595101]). Volition management will host a conference call tomorrow, November 11 at 8:00 a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below.

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"We have enjoyed an exciting quarter navigating the due diligence process and negotiations with three multi-national companies to advance term sheets for Nu.Q Vet licensing and distribution arrangements and anticipate signing a term sheet with one of those parties before the end of 2021," commented Cameron Reynolds, President and Chief Executive Officer of Volition. "We have also made progress in other key areas including our Nu.Q NETs and Nu.Q Capture programs as we shift gears towards our goal of becoming a commercial company with products."

Watch an interview with Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC, Cameron Reynolds, President and Chief Executive Officer of Volition, and Terig Hughes, Chief Financial Officer of Volition: View Source

Company Highlights

Volition Veterinary

In advanced term sheet negotiations with three top global veterinary companies and anticipate signing a term sheet with one of those parties before the end of 2021.
Published two abstracts at the Veterinary Cancer Society Annual Conference including:
the first data published in relation to what will likely be the second Nu.Q Vet product, a disease monitoring tool, on track for a planned launch in 2022; and
the first study using Nu.Q Capture as an enrichment tool in the plasma of dogs with lymphoma.
Financial

Cash and cash equivalents as of September 30, 2021, totalled approximately $22.9 million compared with $19.4 million as of December 31, 2020.
Cash burn rate averaged approximately $1.7 million per month, lower than the rate during the previous two quarters and also below the Company’s expectations.
Net loss for the third quarter of 2021 was $7.2 million versus $5.6 million the prior quarter with this increase primarily due to non-cash items.
Personnel/ Operational

Dr. Gaetan Michel, Chief Operating Officer, has relocated to the U.S. and is tasked with expanding the team with roles expected to be filled in the quality, regulatory and manufacturing functions.
On November 1, Mr. Nick Plummer joined the Company as Group General Counsel.
Intellectual Property

27 patent families (plus three in-licensed families) covering both human and animal use of Volition’s Nucleosomics platform.
82 granted patents (12 in the U.S., 14 in Europe and 56 rest of world).
82 patents pending.
Continued focus on filings during the third quarter of 2021 and expect portfolio to grow in the quarters and years ahead.
Publications

Volition’s list of publications and abstracts continues to grow.
Year to date data for Nu.Q has been presented at four international conferences and Volition has collaborated on four clinical papers.
These publications are another very important step forward for the Company.
Clinical – NETosis including COVID-19

Volition believes the Nu.Q NETs assay will have wide applicability for monitoring diseases with a NETs component (such as COVID-19, influenza, sepsis, autoimmune diseases and cancer) and potentially to risk stratify patients for treatment selection.
Volition expects to register CE marks on its first NETs product, across multiple platforms including ELISA plate, automated beads and a proof of concept on very high throughput platform by the summer of 2022.
Volition intends to register the Nu.Q NETs product with a broad almost C-reactive protein (C.R.P.) style claim "for the detection and evaluation of infection, tissue injury, inflammatory disorders and diseases associated with NETosis".
Posters published this quarter (at the International Society on Thrombosis and Haemostasis Congress) showed that results on admission using the same Nu.Q NETs assay could predict future COVID-19 disease severity and that serial results correlate with disease progression including 28-day mortality.
The Company has further large studies completed in COVID-19 and sepsis which are now awaiting the finalization of data and publication, as well as studies in other diseases in progress with results expected in the coming quarters.
Clinical – Cancer

The Company has completed preliminary analysis of the colorectal cancer studies (both asymptomatic and symptomatic populations) conducted with the National Taiwan University and has submitted these findings for presentation at a conference in early 2022.
The Company has completed preliminary analysis of the lung cancer study also conducted with the National Taiwan University and looks forward to reviewing the data with Professor Chen and his team ahead of publication either through a clinical paper or conference abstract.
Volition has also been in active and continuing negotiations in Asia this year in addition to platform development on its first human cancer launch in China.
Collection for the U.S. EDRN study restarted in June and enrolment has been slow but steady. The EDRN have diverted some efforts to drive recruitment and the Company anticipates study completion in the fourth quarter of 2022.
With regards to Volition’s U.S. blood cancer studies, the timing of expected completion for each has been impacted by the COVID-19 pandemic due to sample collection and protocol issues.
Given the pandemic delays in the larger NHL study (of 1500 subjects) the Company has taken the opportunity to alter the study protocol and are in the process of upgrading the platform to a high-throughput platform which will help facilitate an FDA compliant product. Consequently, Volition now expects this study to initiate recruitment in the first quarter of 2022 with study completion anticipated in 2023.
Upcoming Milestones

Volition expects to achieve the following milestones during the remainder of 2021 and beyond, pandemic permitting:

Drive revenue in the coming quarters in the following key areas:
Licensing of its technology, with a particular but not exclusive focus on Nu.Q Vet, with the aim of signing the first term sheet this year,
Processing samples at Silver One using its Nu.Q Discovery assays, and
Sales of its disease monitoring tests (e.g. COVID-19, sepsis).
Continue to progress the research program for the use of Nu.Q in NETosis, in monitoring disease progression of COVID-19, sepsis and potentially other diseases and as a possible companion diagnostic for a treatment for sepsis.
Continue to advance its previously announced large-scale blood, lung and colorectal cancer trials in Europe, Asia and the U.S.
Publish several abstracts and peer-reviewed scientific papers with clinical results showing the robustness and utility of its Nu.Q platform.
Advance the development of Nu.Q Capture.
Continue to file patents to expand and extend its intellectual property portfolio.
VolitionRx Limited Third Quarter 2021 Financial Results and Business Update

Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with Terig Hughes, Chief Financial Officer of Volition, Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC, and Scott Powell, Executive Vice President, Investor Relations of Volition.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source

In addition, a telephone replay of the call will be available until November 25, 2021. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13725016.