On August 4, 2021 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported that it will report its second quarter 2021 financial results on Wednesday, August 11, 2021 (Press release, Altimmune, AUG 4, 2021, View Source [SID1234585925]).

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Altimmune management will host a conference call for investors beginning at 8:30 am E.T. to discuss the second quarter 2021 financial results and provide a business update.

On August 4, 2021 Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, reported corporate highlights and financial results for the second quarter of 2021 (Press release, Morphic Therapeutic, AUG 4, 2021, View Source [SID1234585675]).

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Recent Highlights and Outlook

Presented positive phase 1 data fully supporting MORF-057 target product profile at the European Crohn’s and Colitis Organisation (ECCO) Virtual Congress 2021

MORF-057 well tolerated at all doses (25 to 400 mg), no safety signals observed
Predictable and dose-dependent pharmacokinetics (PK) surpassing preclinical modeling
Pharmacodynamic (PD) results strongly supportive of MORF-057 continued clinical development

Dose and time dependent α4β7 receptor occupancy including receptor saturation in all subjects at 100 mg BID
Biomarker changes, including lymphocyte subset migration and CCR9 transcript levels, provide early proof of biology
Changes in lymphocyte subsets and CCR9 levels are consistent with published literature on intravenous integrin inhibitors in inflammatory bowel disease (IBD), despite the brief 14-day duration of exposure to MORF-057 in the phase 1 trial
Phase 2a open-label trial design

12-week induction phase with rollover to 40-week maintenance phase in patients with moderate to severe ulcerative colitis scheduled to commence first quarter 2022
The primary endpoint is the change in Robarts Histopathological Index (RHI) at 12 weeks of treatment with MORF-057
Study will assess additional PK and PD measures including the key PD measure of α4β7 receptor occupancy
100 mg BID MORF-057 dose enrolling up to 30-35 patients
All phase 2 readiness work, including chronic toxicology studies, scheduled for completion in third and fourth quarters of 2021
Phase 2b randomized controlled trial design

Global, randomized, placebo-controlled trial enrolling approximately 280 patients with moderate to severe ulcerative colitis, staggered and in parallel to the phase 2a trial
The primary efficacy endpoint will be the proportion of subjects with Mayo Clinic Score Response at 12 weeks and patients will then be followed beyond the 52-weeks of treatment duration
The trial will also measure multiple secondary endpoints including Mayo Clinic Score Remission at 12 weeks, RHI, Patient Reported Outcome scores and translational markers
Multiple dose-ranging cohorts including at least one MORF-057 QD arm, at least one MORF-057 BID arm and one placebo arm
Presented positive preclinical data from Morphic’s immuno-oncology program demonstrating that small molecule inhibition of αvβ8, in combination with checkpoint inhibitors, potentiated anti-tumor activity in tumors refractory to checkpoint inhibition monotherapy
Appointed Susannah Gray, a veteran leader in healthcare finance and strategy with three decades of experience in capital formation, operational management, healthcare asset monetization, investment research and strategy implementations, to the Morphic Board of Directors and the Audit Committee of the Board of Directors
"The MORF-057 program has achieved the selectivity, PK, and PD trinity required for an oral α4β7 inhibitor. I’m extremely proud of the team who designed the molecule and the studies, and now excited to bring this program one step closer to the ultimate goal of helping patients with IBD," said Praveen Tipirneni, M.D., president and chief executive officer of Morphic Therapeutic. "Our vision had two parts. Deliver integrin therapeutics. At scale. With intense technical and business efforts, we’re well on our way to the first. The new MORF-057 clinical data, along with our robust fundraising activities, allow us to now imagine, build and scale our capabilities to advance additional programs including immuno-oncology with our αvβ8 inhibitors."

Financial Results for the Second Quarter 2021

Net loss for the quarter ended June 30, 2021 was $27.8 million or $0.77 per share compared to a net loss of $15.9 million or $0.52 per share for the same quarter last year
Revenue was $3.8 million for the quarter ended June 30, 2021 compared to $7.7 million for the same quarter last year
Research and development expenses were $24.6 million for the quarter ended June 30, 2021 as compared to $19.9 million for the same quarter last year. The increase was primarily due to costs associated with clinical trials costs associated with MORF 057 along with manufacturing costs associated with the upcoming phase 2 clinical trial
General and administrative expenses were $7.1 million for the quarter ended June 30, 2021, compared to $4.2 million for the same quarter last year. The increase was due to an increase in headcount and higher professional and consulting costs associated with Morphic operating as a public company
As of June 30, 2021, Morphic had cash, cash equivalents and marketable securities of $431.6 million, compared to $228.3 million as of December 31, 2020. Morphic believes its cash, cash equivalents and marketable securities as of June 30, 2021, will be sufficient to fund operating expenses and capital expenditure requirements until the end of 2024.

On August 4, 2021 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported financial results for the second quarter ended June 30, 2021 (Press release, NanoString Technologies, AUG 4, 2021, View Source [SID1234585710]).

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Second Quarter Financial Highlights

Product and service revenue of $33.6 million, 59% year-over-year growth
Instrument revenue of $11.8 million, 21% year-over-year growth. Instrument revenue includes $7.4 million of GeoMx Digital Spatial Profiler (DSP) instrument revenue
Consumables revenue of $18.0 million, 115% year-over-year growth. Consumables revenue includes $3.8 million GeoMx DSP consumables revenue
Service revenue of $3.8 million, 29% year-over-year growth
Cash, cash equivalents and short-term investments of $398.0 million at June 30, 2021
"The momentum behind our spatial biology franchise continues to increase with each quarter. We generated record orders for GeoMx DSP systems in the second quarter and the launch of our Whole Transcriptome Atlases have driven a steady increase in GeoMx consumable pull-through. Our Spatial Molecular Imager has been garnering strong interest from a diverse set of researchers, including both existing GeoMx users and single cell researchers who are just beginning to embrace spatial biology," said Brad Gray, president & CEO of NanoString. "Meanwhile, our nCounter franchise achieved a major milestone with our one thousandth instrument placement and we’re proud of the continued scientific contribution from nCounter, with customers generating more than 300 new peer-reviewed publications in the second quarter."

GeoMx DSP

GeoMx Installed Base: Grew installed base to approximately 190 GeoMx DSP Systems at June 30, 2021, as compared to approximately 65 at June 30, 2020
GeoMx Mouse Whole Transcriptome Atlas: Began commercial shipments of the GeoMx Mouse Whole Transcriptome Atlas in the second quarter, which provides high throughput RNA profiling in the primary model organism for discovery research
GeoMx Technology Access Program (TAP): Generated approximately 90 new GeoMx TAP orders in the second quarter, of which over 70% utilized GeoMx Whole Transcriptome Atlas products
GeoMx Publications: Increased cumulative peer-reviewed publications to approximately 60 as of June 30, 2021, with approximately 10 new publications during the quarter
nCounter

nCounter Installed Base: Grew installed base to approximately 1,015 nCounter Analysis Systems at June 30, 2021, as compared to approximately 890 systems at June 30, 2020
nCounter Publications: Surpassed 4,600 cumulative peer-reviewed publications utilizing nCounter technology at June 30, 2021
Stem Cell Characterization Panel Launch: Launched the nCounter Stem Cell Characterization Panel for the analysis and optimization of stem cell lines used in the development of potential novel therapeutics
Parker Institute for Cancer Immunotherapy Collaboration: Announced a collaboration with Parker Institute for Cancer Immunotherapy, which will utilize nCounter technology to characterize cellular therapy regimens that may improve patient outcomes across all cancer types
2021 Outlook

The company updated its revenue outlook for 2021, with results expected as follows:

GeoMx DSP revenue of $48 to $50 million, as compared to previous guidance of $45 to $50 million, based on strong consumable utilization at NGS-enabled sites
nCounter revenue, inclusive of all service revenue, of $95 to $97 million, as compared to previous guidance of $95 to $100 million, reflecting strong demand in North America partially offset by a slower pace of pandemic recovery in EMEA and APAC
Total product and service revenue of $143 to $147 million, as compared to previous guidance of $140 to $150 million
The company reiterated its full-year outlook on gross margin, operating expenses and adjusted EBITDA.

Second Quarter Financial Results

We have elected to present selected non-GAAP, or adjusted, financial measures, including Adjusted EBITDA. These adjusted financial measures are calculated excluding certain items that may make it more challenging to compare our GAAP operating results across periods. Such items may include collaboration revenue, stock-based compensation, depreciation and amortization, or one-time charges such as transaction related fees and expenses or restructuring charges and severance costs. A reconciliation of adjusted financial measures to the nearest comparable GAAP financial measure can be found in the notes and table at the end of this press release.

Supplemental Information

As a supplement to the table above, we have posted to the investor relations section of our website, at www.nanostring.com, supplemental financial data that includes our adjusted financial measures as compared to the nearest comparable GAAP financial measures, for the second quarter and the six months ended June 30, 2021 and for each quarter of and the full year of 2020.

Conference Call

Management will host a conference call today beginning at 1:30 pm PT / 4:30 pm ET to discuss these results and answer questions. Investors and other interested parties can register for the call in advance by visiting View Source After registering, an email confirmation will be sent, including dial-in details and unique conference call codes for entry. Registration is open throughout the call, but to ensure connection for the full call, registration in advance is recommended. The link to the webcast and audio replay will be made available at the Investor Relations website: www.nanostring.com. A replay of the call will be available beginning August 4, 2021 at 7:30pm ET through midnight ET on August 11, 2021. To access the replay, dial (800) 585-8367 or (416) 621-4642 and reference Conference ID: 3414117. The webcast will also be available on our website for one year following the completion of the call.

On August 4, 2021 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported financial results for the second quarter and year-to-date periods ended June 30, 2021 and provided an update on recent company developments (Press release, SpringWorks Therapeutics, AUG 4, 2021, View Source [SID1234585726]).

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"We are very pleased with our execution in the second quarter of 2021, which included continuing to advance our strategy to evaluate nirogacestat as a BCMA potentiator across modalities, building upon our intellectual property portfolio by extending the patent protection for mirdametinib into 2041, and expanding our targeted oncology pipeline through collaborations with leading cancer centers as well as the in-license of a TEAD inhibitor portfolio," said Saqib Islam, Chief Executive Officer of SpringWorks. "In the second half of the year we expect important data readouts across our late-stage rare oncology, BCMA combinations in multiple myeloma and metastatic solid tumor programs, including topline data from our Phase 3 DeFi study. In parallel, we will continue to advance our 15 development programs on behalf of oncology patients."

Recent Business Highlights and Upcoming Milestones

Late-Stage Rare Oncology

SpringWorks expects to report topline data from the Phase 3 DeFi trial evaluating nirogacestat in adult patients with progressing desmoid tumors in the second half of 2021, as previously disclosed.
Recruitment is ongoing in a Phase 2 study sponsored by the Children’s Oncology Group evaluating nirogacestat in pediatric patients with desmoid tumors.
Updated interim data from the adult stratum of the ongoing potentially registrational Phase 2b ReNeu trial evaluating mirdametinib in pediatric and adult patients with NF1-associated plexiform neurofibromas were presented at the 2021 Children’s Tumor Foundation NF Conference in June 2021. These updated data were based on a cut-off date of March 23, 2021 and showed durable efficacy in the same 20 patients reported in February 2021, with the median time on treatment now having reached 13 cycles (approximately 12 months); the objective response rate remained at 50%, and 80% of these patients remained on study at the data cutoff. In addition, mirdametinib remained generally well tolerated; the majority of treatment-related adverse events (TRAE) in these patients were Grade 1 or 2, with only one Grade 3 TRAE observed and no Grade 4 or 5 adverse events (AE) reported in these 20 patients as of the data cutoff. The Company expects to complete enrollment of the trial in the second half of 2021.
In June 2021, SpringWorks entered into a collaboration to conduct a Phase 1/2 clinical trial evaluating mirdametinib in children and young adults with low-grade glioma. Patients are being dosed in this study, which is sponsored by St. Jude Children’s Research Hospital.
B-cell Maturation Antigen (BCMA) Combinations in Multiple Myeloma

In June 2021, SpringWorks entered into a clinical trial collaboration agreement with Seagen Inc. to evaluate nirogacestat in combination with SEA-BCMA, Seagen’s investigational monoclonal antibody targeting B-cell maturation antigen (BCMA) in patients with relapsed or refractory multiple myeloma.
Enrollment is ongoing in four clinical trials evaluating nirogacestat in combination with BCMA therapies in adult patients with relapsed or refractory multiple myeloma: a Phase 1b trial sponsored by GSK evaluating nirogacestat in combination with BLENREP (belantamab mafodotin-blmf), a Phase 1 study sponsored by Allogene evaluating nirogacestat in combination with ALLO-715, a Phase 1 study sponsored by Janssen evaluating nirogacestat in combination with teclistamab, and a Phase 1/2a study sponsored by Precision BioSciences evaluating nirogacestat in combination with PBCAR269A. Initial data from the GSK-sponsored study are expected in 2021. SpringWorks also expects that two additional collaborator-sponsored trials will initiate enrollment in the second half of 2021, as previously disclosed: nirogacestat + Pfizer’s elranatamab and nirogacestat + Seagen’s SEA-BCMA.
Biomarker-Defined Metastatic Solid Tumors

In May 2021, SpringWorks entered into an exclusive worldwide license agreement with Katholieke Universiteit Leuven (KU Leuven) and the Flanders Institute for Biotechnology (VIB) for the in-license of a portfolio of novel small molecule inhibitors of the TEAD family of transcription factors, designed for the potential treatment of biomarker-defined solid tumors driven by aberrant Hippo pathway signaling. The licensed portfolio includes advanced lead compounds and multiple backup compounds from diverse chemical series, which were discovered at KU Leuven’s Center for Drug Design and Discovery (CD3) in collaboration with Professor Georg Halder of the VIB-KU Leuven Center for Cancer Biology. SpringWorks expects to nominate a development candidate from this portfolio and commence IND-enabling studies in 2022.
Enrollment is ongoing in a Phase 1b/2 trial evaluating mirdametinib with BeiGene’s RAF dimer inhibitor, lifirafenib, in adult patients with RAS/RAF mutant and other MAPK pathway aberrant solid tumors. Initial clinical data from the BeiGene-sponsored trial are expected in 2021, as previously disclosed.
Enrollment is ongoing in a Phase 1 trial of BGB-3245 in adult patients with RAF mutant solid tumors. BGB-3245 is a selective RAF dimer inhibitor being developed by MapKure, LLC, a joint venture between SpringWorks and BeiGene. Initial clinical data from the MapKure-sponsored trial are expected in 2021, as previously disclosed.
In August 2021, SpringWorks announced a platform study sponsored by Memorial Sloan Kettering Cancer Center to evaluate mirdametinib both as a monotherapy and as a combination therapy in advanced solid tumors harboring selected MAPK-activating mutations. This trial is planned to initially explore mirdametinib in two patient cohorts: the first in combination with fulvestrant, a selective estrogen receptor degrader, in patients with estrogen receptor-positive metastatic breast cancer with MAPK alterations (particularly inactivating mutations in NF1) and the second as a monotherapy in advanced solid tumors harboring oncogenic MEK1 or MEK2 mutations.
In May 2021, SpringWorks entered into a research collaboration with the University of Zurich to further explore the activity of mirdametinib and lifirafenib combination therapy in preclinical patient-derived NRAS-mutant solid tumors models. The research, which is being led by Reinhard Dummer, M.D., builds upon previous translational work presented by SpringWorks and BeiGene and is intended to support ongoing and future patient selection strategies and to further define the competitive differentiation of the MAPK pathway vertical inhibition strategy supported by the combination of mirdametinib and lifirafenib.
General Corporate

In July 2021, the United States Patent and Trademark Office issued a new composition of matter patent that covers the polymorphic form of mirdametinib that is currently in clinical development. This patent expires in 2041.
SpringWorks appointed Mike Burgess, M.B.Ch.B., Ph.D. as Head of Research and Development and Jim Cassidy, M.D., Ph.D. as Chief Medical Officer. Drs. Burgess and Cassidy each bring decades of experience in oncology drug discovery and development as physician-scientists and R&D leaders at leading biotech and pharmaceutical companies.
Second Quarter 2021 Financial Results

Research and Development (R&D) Expenses: R&D expenses were $32.1 million for the second quarter, compared to $12.9 million for the comparable period of 2020. The increases in R&D expenses were primarily attributable to a nonrefundable upfront payment to KU Leuven and VIB for the in-licensing of the TEAD inhibitor program, an increase in external costs related to drug manufacturing and trial costs, and an increase in internal costs driven by the growth in employee costs associated with increases in the number of R&D personnel and an increase in stock-based compensation expense.
General and Administrative (G&A) Expenses: G&A expenses were $14.9 million for the second quarter, compared to $6.9 million for the comparable period of 2020. The increases in G&A expenses were primarily attributable to the hiring of additional personnel in G&A functions supporting the growth of the organization, as well as an increase in stock-based compensation expense.
Net Loss Attributable to Common Stockholders: SpringWorks reported net loss of $47.0 million, or $0.97 per share, for the second quarter of 2021. This compares to a net loss of $19.9 million, or $0.47 per share, for the comparable period of 2020.
Cash Position: Cash, cash equivalents and marketable securities were $507.5 million as of June 30, 2021.
COVID-19 Update

To date, the COVID-19 pandemic has had a relatively modest impact on SpringWorks’ business operations, in particular on SpringWorks’ clinical trial programs, and SpringWorks is undertaking considerable efforts to mitigate the various challenges presented by this crisis. For further details and descriptions of the risks associated with the COVID-19 pandemic, please see the Risk Factors in SpringWorks’ periodic filings with the Securities and Exchange Commission and refer to the Forward-Looking Statements section in this press release.

On August 4, 2021 PanTher Therapeutics (PanTher), a privately held oncology company revolutionizing the treatment of solid tumors with its proprietary treatment platform designed for direct, localized, and sustained delivery of proven and novel therapeutic agents, reported that it received approval from the Human Research Ethics Committee (HREC) to open a Phase 1 clinical trial of PTM-101 in Australia (Press release, PanTher Therapeutics, AUG 4, 2021, View Source [SID1234585742]). PTM-101 is being developed for the treatment of pancreatic cancer.

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"Pancreatic tumors are notoriously difficult to treat, which is why pancreatic cancer has the highest mortality rate of all major cancers with a 5-year relative survival rate of just 10%," said Laura Indolfi, CEO and Co-Founder of PanTher Therapeutics. "Approval for this first-in-human trial of our lead candidate, PTM-101, brings us one step closer in our journey to deliver effective treatments for the deadliest, most difficult-to-treat cancers."

The company also announced today the appointment of J. Marc Pipas, MD, as Chief Medical Officer and the establishment of its clinical advisory board, composed of key opinion leaders with specific expertise in pancreatic cancer and other solid tumors. Dr. Pipas, a veteran gastrointestinal (GI) oncologist and clinical trialist who has assisted in the development of multiple oncology agents from Phase 1 trials through commercialization, will direct PanTher’s clinical development programs.

Dr. Pipas is a graduate of SUNY-Health Science Center at Syracuse, and completed his Residency at the Medical University of South Carolina, followed by a Fellowship in Medical Oncology at Dartmouth. He spent more than 20 years at Dartmouth Medical School and Dartmouth-Hitchcock Medical Center, where he was promoted to Full Professor and served as Director of the GI Oncology Program, and Interdisciplinary Pancreas Cancer Clinic. He also spent several years as Director of the Office of Clinical Research at the Norris Cotton Cancer Center, a National Cancer Institute-designated Comprehensive Cancer Center, and Director of the Hematology-Oncology Fellowship program.

Following his academic career, Dr. Pipas joined Merrimack Pharmaceuticals as Vice President, Medical Director, where he was involved in program development of ONIVYDE, which received approval from the U.S. Food and Drug Administration for pancreatic cancer and was subsequently sold to Ipsen Pharmaceuticals for $1 billion. Dr. Pipas also served as Executive Medical Director, Clinical Development, for H3 Biomedicine, a subsidiary of Eisai Pharmaceuticals, where he focused his energies on Phase 1 Oncology drug trials in GI and breast cancer.

"PanTher’s unique approach to tackling difficult-to-treat deadly cancers has the potential to change the way oncologists approach patients with solid tumors," said Dr. Pipas. "I am excited to join PanTher at this important moment in the company’s development and look forward to working with the team to capitalize on the strong preclinical data and advance this potentially life-saving platform."

"Dr. Pipas has dedicated his career to bringing new therapies to the clinic, and we are thrilled to have him join the PanTher team," said Indolfi. "He brings a deep commitment to patients that fully aligns with our mission to empower oncologists to treat patients with life-threatening cancers by unlocking a drug’s full potential through targeted treatment at the tumor site."

Dr. Pipas will also chair PanTher’s newly established clinical advisory board, which will play an active role in guiding the company’s long-term strategy and pipeline development. He will be joined by four prominent key opinion leaders with extensive experience in GI oncology:

Thomas E. Clancy, MD, FACS, is co-director of the Pancreas and Biliary Tumor Center and Medical Director of Multispecialty Surgical Oncology at the Dana-Farber/Brigham and Women’s Cancer Center in Boston. His clinical interests include GI malignancies, pancreatic and liver tumors, and minimally invasive surgery. Dr. Clancy is also an Assistant Professor of Surgery at Harvard Medical School, where he received his Doctor of Medicine.
Jason Fleming, MD, is chair of the Department of Gastrointestinal Oncology at Moffitt Cancer Center in Tampa, Florida. Dr. Fleming’s previous roles include Chief of Pancreas Surgery and Professor with tenure in the Department of Surgical Oncology at the University of Texas MD Anderson Cancer Center and scientific and medical advisory board member for the Pancreatic Cancer Action Network (PanCAN). Dr. Fleming has received several notable honors for his work, including the President’s Faculty Recognition Award for Outstanding Contribution to the University of Texas MD Anderson Cancer Center.
Timothy B. Gardner, MD, is Director of the Gastroenterology & Hepatology Fellowship Program and Director of Pancreatic Disorders at Dartmouth-Hitchcock Medical Center. He is also Medical Director of the Islet Cell Transplant Program and is associate professor of medicine at Dartmouth’s Geisel School of Medicine. He specializes in gastroenterology and hepatology with particular focus in endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasound, liver disease, malabsorptive disease, and pancreatic disease.
Theodore (Ted) Sunki Hong, MD, is an accomplished physician-scientist at Massachusetts General Hospital in Boston, where he serves as Director of Gastrointestinal Radiation Oncology and Co-Director of the Tucker Gosnell Center for Gastrointestinal Cancers. In addition to practicing medicine, Dr. Hong conducts research involving targeted therapies for the treatment of GI cancers.