On August 12, 2021 Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the second quarter ending June 30, 2021 and provided a business update (Press release, Savara, AUG 12, 2021, View Source [SID1234586559]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Over the last 9 months we streamlined our portfolio, reduced and restructured the organization, and significantly strengthened the balance sheet so that we could focus solely on advancing the pivotal Phase 3 IMPALA 2 clinical trial," said Matt Pauls, Chair and Chief Executive Officer, Savara. "With the first patient dosed just over one month ago, numerous sites now activated, and patients dosed the trial is progressing as planned and our timelines remain on track. Importantly, we continue to leverage key learnings from the first IMPALA trial so that we can execute IMPALA 2 with the highest efficiency and quality."

Second Quarter Financial Results (Unaudited)
Savara’s net loss attributable to common stockholders for the three months ended June 30, 2021, was $10.9 million, or $(0.07) per share, compared with a net loss attributable to common stockholders of $9.4 million, or $(0.16) per share, for the three months ended June 30, 2020.

Research and development expenses increased by $1.2 million, or 19.3%, to $7.3 million for the three months ended June 30, 2021, from $6.1 million for the three months ended June 30, 2020. The increase was largely attributable to a $3.6 million increase in costs associated with advancement of the molgramostim in aPAP development program and was partially offset by a decrease in Chemistry Manufacturing and Controls (CMC) and clinical operations activities associated with the wind down of the vancomycin hydrochloride inhalation powder development program.

General and administrative expenses were consistent with a slight increase of approximately 1.2%, to $3.2 million for the three months ended June 30, 2021, from $3.1 million for the three months ended June 30, 2020.

As of June 30, 2021, Savara had cash, cash equivalents, and short-term investments of approximately $181 million and debt of approximately $25 million.

On August 12, 2021 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, reported financial results and provided a corporate update for the second quarter ended June 30, 2021 (Press release, Tempest Therapeutics, AUG 12, 2021, View Source [SID1234586558]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"The second quarter of 2021 was an exciting period as Tempest became a public company and the team drove progress in all three of our novel programs," said Steve Brady, chief executive officer of Tempest. "We look forward to the planned opening of the TPST-1120 randomized study in first line hepatocellular carcinoma in collaboration with Roche and the first combination study of TPST-1495, and remain focused on delivering potentially value-creating milestones over the next year and beyond."

Recent Highlights

Public Company Transition: successfully closed merger and concurrent PIPE financing, allowing Tempest to become a public company listed on the Nasdaq Capital Market, and extending runway into 2023 through multiple potential catalysts.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): continued enrollment in monotherapy dose optimization towards recommended Phase 2 dose ("RP2D").
TPST-1120 (clinical PPARα antagonist): (i) completed monotherapy dose escalation and selected 600mg BID as RP2D; (ii) observed stable disease ("SD") in 50% of the monotherapy-treated patients, including prolonged SD in patients with refractory cholangiocarcinoma; and (iii) observed a deep, confirmed partial response in a patient with checkpoint inhibitor-refractory fourth line renal cell carcinoma in the combination study with nivolumab (->60% by RECIST 1.1, durable through 4 scans and ongoing).
TREX-1 Inhibitor (preclinical, tumor-selective STING pathway activator): (i) progressed lead series to picomolar IC50 potency in biochemical assays; and (ii) demonstrated significant proof of concept in a mouse tumor model with systemic delivery of a lead series molecule.
Board of Directors: Christine Pellizzari, J.D., Geoff Nichol, M.B., Ch.B., M.B.A., and Ronit Simantov, M.D., joined the Board of Directors, bringing deeper financial, legal, and clinical development expertise to Tempest.
Planned Near-Term Milestones

TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) selection of monotherapy RP2D expected in the first half of 2022; (ii) commencement of a combination study with an anti-PD-1 checkpoint inhibitor expected prior to the end of 2021; and (iii) commencement of monotherapy expansion in targeted indications and biomarker-selected patient populations expected in the first half of 2022.
TPST-1120 (clinical PPARα antagonist): (i) identification of RP2D of TPST-1120 in combination with nivolumab expected prior to the end of 2021; and (ii) commencement of first line randomized Phase 1b/2 study in hepatocellular carcinoma patients, under a collaboration with F. Hoffman La Roche, expected within the third quarter.
TREX-1 Inhibitor (preclinical tumor-selective STING pathway activator): planned selection of development candidate in the first half of 2022.
Financial Results

Second Quarter

Tempest ended the second quarter of 2021 with $68.5 million in cash and cash equivalents and short-term restricted cash, compared to $18.8 million in December 31, 2020. The increase was primarily due to the merger and concurrent PIPE, which closed in June 2021.
Net loss and net loss per share for the second quarter of 2021 were $7.1 million and $7.63, respectively, compared to $5.2 million and $11.42, respectively, for the second quarter of 2020. The increase was primarily due to an increase in compensation expense and professional fees associated with the merger.
Research and development expenses for the second quarter of 2021 were $4.2 million, compared to $4.1 million for the same period in 2020. The $0.1 million increase was primarily attributable to increased compensation expenses.
For the three months ended June 30, 2021, general and administrative expenses were $2.6 million compared to $1.1 million for the same period in 2020. The increase was primarily due to growth in compensation expense and professional fees associated with the merger.
Year-to-Date

Net cash used in operations for the six months ended June 30, 2021 was $6.2 million.
Net loss and net loss per share for the six months ended June 30, 2021 were $12.4 million and $17.30, respectively, compared to $9.5 million and $21.28, respectively, for the same period in 2020.
Research and development expenses for the six months ended June 30, 2021 were $7.8 million compared to $7.1 million for the same period in 2020. The $0.7 million increase was primarily due to increased compensation expenses and consulting services.
For the six months ended June 30, 2021, general and administrative expenses were $4.1 million compared to $2.4 million for the same period in 2020.

On August 12, 2021 Cytocom, Inc. (NASDAQ: CBLI), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, reported a collaboration agreement to fund research and laboratory facilities at the La Jolla Institute for Immunology (LJI), a not-for-profit academic institution and a world leader in immunology research (Press release, Cytocom, AUG 12, 2021, https://www.cytocom.com/2021/08/12/cytocom-inc-and-la-jolla-institute-for-immunology-announce-five-year-research-alliance-agreement/?utm_source=rss&utm_medium=rss&utm_campaign=cytocom-inc-and-la-jolla-institute-for-immunology-announce-five-year-research-alliance-agreement [SID1234586542]). The agreement is directed to research that will support the development of potential new immune-modulating agents targeting toll-like receptors for the treatment of cancer, infectious, autoimmune and chronic inflammatory diseases. The research will harness Cytocom’s proprietary drug discovery and development platform technology.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"An alliance with an academic institution the caliber of the La Jolla Institute marks a major achievement for Cytocom and our mission to advance best-of-class immune-modulating therapies that restore immune homeostasis," stated Michael K. Handley, President and CEO of Cytocom. "With the completion of the merger between Cleveland BioLabs and Cytocom, we have built a robust pipeline of immune-modulating treatments targeting neutropenia and anemia, emergent viruses, cancer, and autoimmune diseases. Working with the La Jolla Institute, we will deeply explore the mechanisms that we believe will drive next-generation therapeutic development with our AIMS technology and bring hope to patients and their families battling serious medical conditions."

Under the terms of the research agreement, the La Jolla Institute may select up to four laboratories to participate in research. Cytocom will provide research funding to these laboratories for projects of mutual interest or for research projects commissioned by Cytocom that explore immune modulation and the action of therapeutics on target toll-like receptors. Toll-like receptors are central to an immune response, connecting innate and adaptive immune compartments, and thus key to fighting disease as well as restoring immune homeostasis. In addition to the research funding for the selected projects, Cytocom will pay to the La Jolla Institute $350,000 per year for each selected laboratory, for a total annual discretionary funding contribution of up to $1.4 million, in addition to the research funding itself. Cytocom will also provide researchers at the La Jolla Institute with samples and materials. In return, Cytocom will have a first option to negotiate a license to new discoveries by the La Jolla Institute that arise from the research projects of common interest funded by Cytocom, however Cytocom will own any new discoveries that arise from research projects of interest to Cytocom that have been commissioned to the La Jolla Institute as "work for hire."

"We are excited to work with Cytocom to interrogate the mechanisms of immune modulation and human immunity modulated through toll-like receptors," stated La Jolla Institute President and Chief Scientific Officer Mitchell Kronenberg, Ph.D. "Collaborations between academic research organizations and the biopharmaceutical industry play a key role in advancing science and informing drug development to the benefit everyone involved, from discovery-oriented scientists to therapeutic-oriented companies. Such collaborations are an important element of our history and our mission looking to the future. Most importantly, the combined efforts provide hope to the millions of people worldwide who deserve immunotherapies that deliver a healthy life without disease."

On August 12, 2021 Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as ‘Lynk Pharmaceuticals’), an innovative drug development company, reported that it has administered its triple-kinase inhibitor LNK01002 to the first patient in a phase I clinical trial (Press release, Lynk Pharmaceuticals, AUG 12, 2021, View Source [SID1234586540]). This is a multi-center, open label phase I clinical study to evaluate the safety, tolerance and pharmacokinetics of LNK01002 in patients with primary myelofibrosis (PMF) and secondary myelofibrosis (PV/ET-MF) induced by polycythemia vera or primary thrombocytosis.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

LNK01002 is an innovative triple-kinase inhibitor independently developed by Lynk Pharmaceuticals. LNK01002 simultaneously targets three kinase drivers of PMF and PV/ET-MF with the potential to effectively treat patients who are not responsive, or have developed resistance to, conventional therapies and thus addresses a global unmet clinical need with a potential first in class therapy.

"In preclinical studies, we have demonstrated better anticancer activity and safety in comparison with other mono- or dual-kinase inhibitors", said Dr. Sherry Weigand, Chief Medical Officer of Lynk Pharmaceuticals, "Rapid clinical studies of LNK01002 in patients will accelerate evaluating its therapeutic value more quickly and thoroughly. As a novel therapy, we hope that LNK01002 will benefit patients in need as soon as possible."

"This first-in-patient study of LNK01002 is an important milestone, as it formally marks the start of its clinical stage of studies." said Zhao-Kui (ZK) Wan, Founder and CEO of Lynk, "we look forward to seeing the clinical outcomes, and hope LNK01002 will bring a better and additional treatment for the patients worldwide."

On August 12, 2021 Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, reported results for the second quarter of 2020 and provided a corporate and clinical update (Press release, AmpliPhi Biosciences, AUG 12, 2021, View Source [SID1234586536]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

During the quarter, the Company announced a $15 million award from the U.S. Department of Defense, through the Medical Technology Enterprise Consortium (MTEC) with funding from the Defense Health Agency and Joint Warfighter Medical Research Program, for a three-year program to advance development of AP-SA02 in S. aureus bacteremia infections. Armata will use the award to partially fund a Phase 1b/2 randomized, double-blind, placebo-controlled, dose escalation clinical study. The Company expects to initiate the clinical trial next year.

"The highlight of the second quarter was our announcement of the $15 million award from the U.S. Department of Defense to advance AP-SA02, which we are developing as a potential treatment for Staphylococcus aureus bacteremia infections. In an ongoing effort to prudently manage our cash, we sought non-dilutive third-party funding to help advance this program, and we exceeded the amount that we were initially targeting. We are in the process of developing an efficient clinical plan for this promising candidate, and this award will now allow us to initiate a Phase 1b/2 clinical trial as expeditiously as possible," said Todd R. Patrick, Chief Executive Officer of Armata. "With respect to our lead program, subject to potential delays related to COVID-19, we believe we are on track to initiate our Phase 1b/2a clinical trial of AP-PA02 in Pseudomonas aeruginosa infections in cystic fibrosis patients later this year. Finally, we remain well capitalized with $19.8 million of cash on our balance sheet as of June 30, 2020."

Anticipated 2020 and 2021 Milestones:

Initiate a Phase 1b/2a clinical trial evaluating AP-PA02 as a potential treatment for Pseudomonas aeruginosa infections by the end of 2020
Initiate a Phase 1b/2 clinical trial evaluating AP-SA02 as a potential treatment for Staphylococcus aureus bacteremia infections in 2021
Continue to screen pathogens against the Company’s proprietary phage library to identify additional high-quality bacteriophage product candidates and expand the pipeline.
Second Quarter Financial Results

Research and Development. Research and development expenses for the three months ended June 30, 2020 were approximately $2.6 million as compared to $3.1 million for the comparable period in 2019.

General and Administrative. General and administrative expenses for the three months ended June 30, 2020 were $2.0 million as compared to $2.1 million for the comparable period in 2019.

Loss from Operations. Loss from operations for the three months ended June 30, 2020 was $4.7 million as compared to $4.2 million for the comparable period in 2019.

Cash and Equivalents. As of June 30, 2020, Armata held $19.8 million of unrestricted cash and cash equivalents, as compared to $6.0 million as of December 31, 2019. Management believes the Company’s existing resources will be sufficient to fund planned operations through at least the first half of 2021.

As of August 13, 2020, there were approximately 18.7 million shares of common stock outstanding.