On November 10, 2021 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), reported that strategic, financial, and operational updates for the third quarter ended September 30, 2021 (Press release, Heat Biologics, NOV 10, 2021, View Source [SID1234595090]).

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Jeff Wolf, Chief Executive Officer of Heat, commented, "Our clinical and preclinical programs are progressing well. In September, we expanded dosing in our Phase 1 clinical trial of monoclonal antibody PTX-35 in patients with solid tumors, and are planning a clinical development pathway to utilize PTX-35 in the context of inflammatory disease. We are also preparing for an end of Phase 2 meeting with the FDA for HS-110 to discuss potential Phase 3 registration pathways."

"Additionally, we recently announced our new biosecurity/biodefense initiative, which leverages our gp96 platform against known or unknown future biological threats. In the short time since launching this program, we have filed patents to protect our proprietary technology and have established collaborations with leading institutions to advance our research. At the same time, we’ve assembled a knowledgeable and experienced biothreat advisory board that is well-versed on our biothreat platform. We plan to provide further updates on our biodefense efforts in the near future."

"Our strategic vision is to become a fully integrated, immune system-focused biopharmaceutical company, and we continue to evolve in that direction. In August we announced the groundbreaking of our new wholly-owned Scorpion biomanufacturing and bioanalytic subsidiary, which is designed to support our internal manufacturing needs as we advance our programs as well as to offer much-needed biomanufacturing/bioanalytic services to other biotech and pharmaceutical clients. Our ultimate goal is to reduce development costs, accelerate development timelines, and ensure the highest levels of quality by controlling the entire process internally. Overall, we have maintained a solid balance sheet and are well positioned to execute on a number of key milestones that we believe will drive significant value for shareholders."

Third Quarter 2021 Financial Results

Recognized $0.5 million of grant revenue for qualified expenditures under the CPRIT grant for the quarter ended September 30, 2021 compared to $0.8 million for the quarter ended September 30, 2020. The decrease in grant revenue in the current-year period primarily reflects the expected timing of completion of deliveries under the current phase of the contracts. As of September 30, 2021, we had a grant receivable balance of $0.9 million for CPRIT proceeds not yet received but for which the costs had been incurred or the conditions of the award had been met. We continue our efforts to secure future non-dilutive grant funding to subsidize ongoing research and development costs.
Research and development expense was $4.4 million and $3.2 million for the three months ended September 30, 2021 and 2020, respectively.
General and administrative expense was $3.4 million and $6.6 million for the three months ended September 30, 2021 and 2020. The decrease was primarily due to a decrease in stock-based compensation expense of $3.9 million.
Net loss attributable to Heat Biologics was approximately $7.4 million, or ($0.30) per basic and diluted share for the quarter ended September 30, 2021 compared to a net loss of approximately of $8.9 million, or ($0.43) per basic and diluted share for the quarter ended September 30, 2020.
As of September 30, 2021, the Company had approximately $108.9 million in cash, cash equivalents and short investments.

On November 10, 2021 Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical needs, reported its cash position as of September 30, 2021 and its revenues for the first nine months of 2021 (Press release, Inventiva Pharma, NOV 10, 2021, View Source [SID1234595106]).

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Cash Position

As of September 30, 2021, Inventiva’s cash and cash equivalents stood at €105.7 million, compared to €93.6 million as of June 30, 2021 and €105.72 million as of December 31, 2020.

Net cash used in operating activities amounted to €31.6 million for the first nine months of 2021 compared to (€19.4) million for the same period in 2020. R&D expenses for the first nine months of 2021 were up by 88% compared to the same period in 2020, mainly driven by the costs associated with the preparation and initiation of the NATiV3 Phase III clinical trial with lanifibranor in NASH, and to a lesser extent, by the increase of general and administrative expenses (G&A) expenses (+ 51%) resulting from Inventiva’s dual listing status.

Net cash generated from financing activities for the first nine months of 2021 amounted to €23.9 million, mainly due to the sale of $30 million in gross proceeds of the Company’s ordinary shares in the form American Depositary Shares ("ADS") on September 23, 2021. The sale was made through the Company’s At-The-Market (ATM) program established on August 2, 2021, to existing and new specialized institutional investors. For the same period in 2020, net cash generated from financing activities amounted to €111.6 million, driven by: the issuance of €15 million (gross proceeds) of ordinary shares to certain existing investors in the Company, the entry into €10 million in French state-guaranteed credit agreements with a syndicate of French banks, and the receipt of €94.9 million3 (gross proceeds) following the successful IPO on the Nasdaq Global Market in July 2020.

Over the third quarter of 2021, the Company recorded a positive exchange rate effect on cash and cash equivalents of €3.0 million.

Considering its current R&D and clinical development programs and excluding additional financial resources that may originate from funding activities, Inventiva’s cash runway will allow the Company to fund its operations through the first quarter of 2023.

Revenues

The Company’s revenues for the first nine months of 2021 amounted to €0.2 million, as compared to €0.3 million for the same period in 2020. As part of its collaboration with AbbVie in auto-immune diseases, Inventiva is eligible to receive development, regulatory and commercial milestone payments as well as royalty payments. As such, the Company expects to receive another milestone payment upon the initiation by AbbVie of the Phase IIb clinical trial with cedirogant planned before the end of 2021.

Update on the Phase II clinical trial with lanifibranor in patients with NAFLD and T2D

The Phase II investigator-initiated clinical trial evaluating lanifibranor for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) in patients with type 2 diabetes (T2D) is progressing and Professor Cusi is recruiting the last patients of the trial. However, given the current status of recruitment, the publication of the results is now expected for the second half of 2022, rather than the first half of 2022 as previously communicated.

Next key milestones expected

Webcast with Key Opinion Leaders from the AASLD The Liver Meeting 2021 hosted by Inventiva – scheduled on November 19, 2021
Initiation by AbbVie of the Phase IIb clinical trial with cedirogant in patients with moderate to severe psoriasis – planned for November 2021
Activation of first clinical sites for Phase IIa combination trial with lanifibranor and SGLT2 inhibitor empagliflozin in patients with NASH and T2D – planned for the first half of 2022
Last Patient First Visit of the NATIV3 Phase III clinical trial evaluating lanifibranor in NASH – planned for the second half of 2022
Publication of the results of the Phase II clinical trial evaluating lanifibranor for the treatment of NAFLD in patients with T2D – planned for the second half of 2022
Strategy update on the development of odiparcil – planned for 2022
Upcoming investor conference participation

Stifel Healthcare Conference 2021 – November 16-17, 2021
Jefferies 2021 London Healthcare Conference – November 16-18, 2021
J.P. Morgan Healthcare Conference 2022 – January 10-13, 2021
Upcoming scientific conference presentations

AASLD The Liver Meeting, November 12-15, 2021
Next financial results publication

Full-Year 2021 Revenues and cash position: Monday, February 14, 2022 (after U.S. market close)

On November 10, 2021 Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported that management will participate in two upcoming virtual investor conferences (Press release, Harpoon Therapeutics, NOV 10, 2021, View Source [SID1234595123]):

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A fireside chat at Stifel’s 2021 Virtual Healthcare Conference on Monday, November 15, 2021 at 4 p.m. ET / 1 p.m. PT; and

A pre-recorded fireside chat at Piper Sandler’s 33rd Annual Healthcare Conference will be available on the conference website beginning at 10 a.m. ET / 7 a.m. PT on November 22, 2021. A link to the fireside chat will also become available at the same time on the Harpoon website on the Events page. Harpoon will be participating in 1×1 meetings with investors on Tuesday, November 30, and meetings can be requested exclusively via Piper Sandler.
The webcasts will be available from the Events and Presentations section of the company’s website at View Source and will be archived there shortly after the events.

On November 10, 2021 Inspirna, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and biologic cancer therapeutics, reported that CEO Masoud Tavazoie, M.D., Ph.D., will present at the Stifel 2021 Virtual Healthcare Conference at 10:40 A.M. EST on November 17, 2021 (Press release, Inspirna, NOV 10, 2021, View Source [SID1234595139]).

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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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To view this virtual presentation, live, register for the event here.

Links to the live and archived version of this presentation will also be available on Inspirna’s website within the News section.

On November 10, 2021 Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, reported third quarter 2021 financial results and a corporate update (Press release, Ryvu Therapeutics, NOV 10, 2021, View Source [SID1234595155]).

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"In the third quarter Ryvu has achieved several important milestones for its proprietary pipeline programs", said Pawel Przewiezlikowski, Chief Executive Officer of Ryvu.

"We are excited to announce the latest clinical and translational data for our most advanced project RVU120 at the upcoming ASH (Free ASH Whitepaper) and SABCS conferences, and our preclinical data on HPK1 and STING compounds at the SITC (Free SITC Whitepaper) conference in November. These encouraging data further reinforce the therapeutic potential of our programs, and we look forward to seeing how our discovery and research are translating into a tangible promise for cancer patients."

Recent Highlights

Two Poster Presentations of HPK1 and STING programs at SITC (Free SITC Whitepaper)’s 36th Annual Meeting
Ryvu will present a poster on novel, orally administered HPK1 inhibitors which exhibit nanomolar activity in an immunosuppressive environment. These small molecules have shown favorable PK profiles allowing for in vivo target engagement after oral administration, and hold promising potential as a treatment in a variety of solid tumor indications.

The second poster will highlight a novel small-molecule STING agonist, RVU-27065. Selective STING pathway activation with RVU-27065 allows for repolarization of immunosuppressive tumor-associated macrophages into a pro-inflammatory phenotype without a negative impact on T-cell functioning. With favorable drug-like properties and good safety profile, RVU-27065 is a promising candidate for standalone treatment as well as targeted delivery as a payload for antibodies.

Presentation of clinical and translational data from RVU120 and SEL24/MEN1703 at the 63rd "ASH" Annual Meeting & Exposition and the 44th Annual SABCS
On November 4, Ryvu announced that, together with its collaborators from MD Anderson Cancer Center and the Menarini Group, it will present six posters showing new data demonstrating clinical and preclinical activity of its selective CDK8/19 inhibitor RVU120 (SEL120) and selective PIM/FLT3 inhibitor SEL24 (MEN1703) during the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition and at the 44th Annual San Antonio Breast Cancer Symposium (SABCS).

The posters to be presented include: initial data from ongoing Phase Ib of RVU120 which demonstrates an acceptable safety profile and early signs of efficacy, including a Complete Remission (CR) within the first five dose cohorts; an ongoing dose escalation in AML and HR-MDS; translational research for RVU120 demonstrated a strong trend of efficacy in DNMT3A-mutated AML patient-derived cells; preclinical models showing potential for clinical efficacy of RVU120 in breast cancer. Ryvu licensee, Menarini Group will be presenting SEL24/MEN1703 data from the first-in-human, dose-escalation and cohort expansion CLI24-001 trial.

Ryvu’s partner Menarini Group receives FDA Orphan Drug Designation for SEL24 (MEN1703) for the Treatment of Acute Myeloid Leukemia
On November 4, Menarini Group announced that the FDA has granted an ODD to SEL24/MEN1703, a first-in-class, orally available, dual PIM/FLT3 inhibitor, in-licensed by Menarini Group from Ryvu. Currently SEL24/MEN1703 is being examined as part of the DIAMOND-01 trial as a single agent for the treatment of patients with AML. DIAMOND-01 is a First-in-Human, Phase I/II, dose escalation and cohort expansion trial of SEL24/MEN1703, investigated as a single agent for the treatment of patients with AML.

First patient dosed in Phase I/II study of RVU120 (SEL120) in patients with relapsed/refractory (R/R) metastatic or advanced solid tumors
On August 25, Ryvu announced that the first patient was dosed in the Phase I/II clinical trial investigating RVU120 in relapsed/refractory metastatic or advanced solid tumors. The single-agent, open-label Phase I/II trial is currently enrolling patients in Poland, and site expansion to Spain is in progress.

Publication of research on MCT4 inhibitors in the Journal of Medicinal Chemistry
On August 8, a joint publication of researchers from Ryvu Therapeutics and Merck KGaA on the discovery, development, and optimization of selective MCT4 inhibitors was published in the Journal of Medicinal Chemistry: "Discovery of 5-{2-[5-Chloro-2-(5-ethoxyquinoline-8-sulfonamido)phenyl]ethynyl}-4-methoxypyridine-2-carboxylic Acid, a Highly Selective in Vivo Useable Chemical Probe to Dissect MCT4 Biology."

In Q3 2021, Ryvu participated in the following investor conferences:

Morgan Stanley 19th Annual Global Healthcare Conference (September 9 – 15), where Ryvu’s Chief Business Officer, Vatnak Vat-Ho participated in a fireside chat as well as hosted investor meetings during the conference. 
H.C. Wainwright 23rd Annual Global Investment Conference (September 13 -15), where Ryvu presented during the event as well as hosted investor meetings.
Ryvu 2021 Third Quarter, Financial Results

In the nine months of 2021, the Company reported PLN 19.6 million (USD 5.1 million) of revenues. Over 90% of this number were grants (PLN 18.2 million or USD 4.8 million) and the remainder consisted of income from partnering (PLN 0.5 million or USD 0.1 million), other revenues (PLN 0.5 million or USD 0.1 million) and other operating revenues in total PLN 0.4 million (USD 0.1 million).

Operating costs, excluding the non-cash expense of the Incentive Program (PLN 15.0 million or USD 3.9 million), in the audited period amounted to PLN 66.2 million (USD 17.4 million), and related primarily to research and development expenditures, while the operational loss without the Incentive Program was PLN 46.6 million (USD 12.2 million) compared to PLN 24.2 million (USD 6.1 million) reported in the corresponding period in 2020. Net loss without the Incentive Program for the nine months of 2021 amounted to PLN 45.6 million (USD 12.0 million) and the reported loss for the corresponding period of 2020 amounted to PLN 20.7 million (USD 5.3 million).

On October 31, 2021, Ryvu Therapeutics held PLN 84.9 million (USD 21.3 million) in cash, cash equivalents, and short-term investments.