On November 7, 2019 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage, immunotherapy and targeted oncology company, reported financial results and recent corporate highlights for the third quarter ended September 30, 2019 (Press release, Checkpoint Therapeutics, NOV 7, 2019, View Source [SID1234550712]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We achieved a key inflection point in September with the presentation of positive interim clinical results for cosibelimab (formerly CK-301), our fully human anti-PD-L1 antibody, at the European Society for Medical Oncology ("ESMO") Congress 2019. These compelling clinical data demonstrated anti-tumor activity across multiple advanced cancers, with a 50% objective response rate observed in cutaneous squamous cell carcinoma ("CSCC"), a 40% objective response rate observed in non-small cell lung cancer ("NSCLC"), as well as a well-tolerated safety profile across all cohorts. These results highlight the potential of cosibelimab to be potentially differentiated from other drugs in its class, in addition to our intended commercial strategy to position cosibelimab as a lower-cost alternative to available anti-PD-1/L1 mAbs. Enrollment in this trial is ongoing and, with additional data, could support the submission of an initial Biologics License Application ("BLA") for cosibelimab in CSCC. We also look forward to soon reporting additional clinical data for CK-101, our novel, oral, third-generation epidermal growth factor receptor ("EGFR") inhibitor, in order to support the potential initiation of a Phase 3 clinical trial in first-line EGFR mutation-positive NSCLC."

Financial Results:

Cash Position: As of September 30, 2019, Checkpoint’s cash and cash equivalents totaled $13.1 million, compared to $13.2 million as of June 30, 2019, and $22.0 million as of December 31, 2018, a decrease of $0.1 million for the quarter and a decrease of $8.9 million year-to-date.
R&D Expenses: Research and development expenses for the third quarter of 2019 were $3.9 million, compared to $7.8 million for the third quarter of 2018, a decrease of $3.9 million. Research and development expenses for the third quarter of 2019 included $0.2 million of non-cash stock expenses, compared to $0.6 million in stock compensation expense for the third quarter of 2018. The Company expects that for the balance of 2019, research and development expenses will continue to remain lower than the comparable period in 2018.
G&A Expenses: General and administrative expenses for the third quarter of 2019 were $1.6 million, compared to $1.5 million for the third quarter of 2018, an increase of $0.1 million. General and administrative expenses for the third quarters of 2019 and 2018 each included $0.7 million of non-cash stock expenses.
Net Loss: Net loss attributable to common stockholders for the third quarter of 2019 was $5.2 million, or $0.15 per share, compared to a net loss of $9.3 million, or $0.32 per share, for the third quarter of 2018. The net loss for the third quarter of 2019 included $0.9 million of non-cash stock expenses, compared to $1.3 million for the third quarter of 2018.

On November 7, 2019 NanOlogy LLC, a clinical-stage oncology company, reported that interim data were presented last week at the 2019 ACG annual meeting from two of its clinical trials each evaluating endoscopic ultrasound guided fine needle injection (EUS-FNI) of NanoPac (submicron particle paclitaxel): one for treatment of locally advanced pancreatic cancer (LAPC) and the other for treatment of mucinous cystic neoplasms of the pancreas (MCNs) (Press release, NanOlogy, NOV 7, 2019, View Source [SID1234550711]).

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The pancreatic cancer clinical update of intratumoral NanoPac for treatment of LAPC was presented by Simon K. Lo, MD (Cedars-Sinai) as part of the Pancreatic Cancer/Esophagus plenary session.

The Phase 2a dose-rising and expansion pancreatic cancer trial is evaluating the safety and preliminary efficacy of NanoPac delivered intratumorally by EUS-FNI over 6 months in patients with nonresectable LAPC. After completion of the dose-rising phase, the trial has now enrolled 16 of 22 subjects into the dose expansion phase of the trial in which patients are receiving two intratumoral injections of NanoPac 4 weeks apart.

Highlights from Dr. Lo’s presentation on the dose expansion phase of the trial:

No drug-related local or systemic serious adverse events have been reported to date (n=25) including no reports of acute pancreatitis.
Of 7 subjects who have completed the 6-month study to date, one subject had a partial response with restaging from nonresectable to resectable (see video), 3 had stable disease, 1 had progressive disease, and 2 were withdrawn from the study.
Tumor volume decreases ranging from 7% to 76% have been seen in 7 of 11 subjects upon latest mpMRI to date at either the 3- or 6-month time point.
CA19-9 reductions of greater than 20% have been seen in 5 of 11 subjects upon latest measure to date at either the 3- or 6-month time point.
The pancreatic cyst clinical update on intracystic NanoPac for treatment of MCNs of the pancreas was presented during the poster sessions by Mohamed O. Othman, MD (Baylor College of Medicine). Dr Othman’s poster was recognized as a Presidential Poster, a distinction given to fewer than 5% of accepted abstracts each year, and was ultimately named co-winner for high quality, novel, unique and interesting research.

The Phase 2a dose rising and expansion pancreatic cyst trial is evaluating the safety and preliminary efficacy of NanoPac delivered intracystically by EUS-FNI following aspiration in patients with MCNs. The study is also enrolling in the dose expansion phase of the study and patients are receiving two intracystic injections of NanoPac 12 weeks apart.

Highlights from Dr. Othman’s poster presentation on the trial:

No drug-related local or systemic serious adverse events (SAE) have been reported to date (n=15) including no reports of acute pancreatitis. One case of gastric outlet obstruction that was possibly drug-related occurred in a subject who had a recent unrelated endoscopic procedure for hepatobiliary dysfunction. This condition was subsequently added as an exclusion criterion for the trial.
Plasma paclitaxel levels for all subjects analyzed have not exceed 1ng/mL suggesting that NanoPac particles are retained in the cyst over time.
Cyst volume decreases ranging from 8% to 89% have been seen in 9 of 11 subjects at last available imaging at either the 3- or 6-month time point.
Nanology plans to design follow-on clinical trials for both pancreatic cancer and pancreatic cysts in 2020 to further advance the programs toward regulatory submission.

In 2019, an estimated 57,000 new cases of pancreatic cancer will be diagnosed in the U.S. and 46,000 people will die from the disease. Pancreatic cancer is among the deadliest cancers with 9% survival rate at 5 years. It is also one of the few cancers for which no meaningful improvement in survival has been achieved in the last two decades. MCNs are a subset of pancreatic cysts that risk progression to pancreatic cancer. Patients with high risk MCNs may undergo surgical resection of the pancreas to remove the lesion, a complicated procedure associated with mortality and morbidity rates of 2% and 30% respectively. For both the disease itself and one of its common precursors, Nanology investigational drugs may offer a new way to help prevent or treat pancreatic cancer.

In addition to these trials, NanOlogy is advancing its therapeutic platform in preclinical and clinical programs across genitourinary, peritoneal, lung, and dermal cancers. The NanOlogy therapeutic platform is based on a proprietary submicron particle production technology that reduces the size of taxane API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The characteristics of the particles have recently been granted a composition of matter patent valid in the US (9,814,685) and Australia until 2036, and pending globally.

On November 7, 2019 Molecular Templates, Inc. (Nasdaq: MTEM), a clinical-stage biopharmaceutical company focused on the discovery and development of the company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer, reported that it will host an analyst & investor breakfast on November 15th from 8:00am to 10:00am ET in New York City (Press release, Molecular Templates, NOV 7, 2019, View Source [SID1234550710]).

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The meeting will feature presentations by Key Opinion Leaders (KOLs) Matthew McKinney, MD, from Duke University, and Zev Wainberg, MD, from UCLA, who will discuss the current treatment landscape and unmet medical need in treating patients with diffuse large B-cell lymphoma and HER2-positive cancers, respectively. Additionally, John Newcomb, PhD, Director in the Immuno-Oncology Drug Discovery Unit at Takeda Pharmaceuticals, will discuss partnered asset TAK-169, a 2nd generation de-immunized ETB targeting CD38 in multiple myeloma. All of the speakers will be available to answer questions at the conclusion of the event.

The event will also feature a presentation by Molecular Templates’ management team, who will provide an overview of the Company’s R&D pipeline and updates on key clinical programs.

Discussion topics will cover:

MTEM corporate overview provided by Eric Poma, PhD, CEO & CSO of MTEM
Matthew McKinney, MD, will present the current treatment outlook for diffuse large B-cell lymphoma (DLBCL)
MTEM’s CMO, Roger Waltzman, MD, will review the company’s lead program, MT-3724, an ETB targeting CD20, that is being developed for the treatment of DLBCL
John Newcomb, PhD, will review TAK-169 targeting CD38 in multiple myeloma
Zev Wainberg, MD, will discuss the current treatment landscape for HER2-positive cancers
This event is intended for institutional investors and sell-side analysts only. Please RSVP in advance if you plan to attend, as space is limited. For those unable to attend in person, a live webcast and replay will be accessible via the News & Events page on the Investor Relations tab of the Molecular Templates website or by clicking here.

KOL Biographies

Matt McKinney, MD, is an Assistant Professor of Medicine at the Duke University School of Medicine. He specializes clinically in lymphomas and the majority of his clinical practice involves the care of patients with aggressive lymphomas such as diffuse large B cell lymphoma. Additionally, he focuses a significant amount of his effort on clinical and translational research involving novel therapeutics and the use of genomics to guide therapy and improve prognostic models in non-Hodgkin’s lymphomas. He has been the recipient of several awards for his research and clinical work and he has published research in many well respect peer-reviewed journals including Nature Genetics, Cancer Discovery, Journal of Experimental Medicine, and Clinical Cancer Research.

Zev Wainberg, MD, received his medical degree from Tel Aviv University Sackler School of Medicine, New York Program, in 2000. He did his internship and residency in Internal Medicine at Montefiore Medical Center Moses Division Hospital, Albert Einstein College of Medicine, from 2000-2003. He completed his three-year fellowship in Hematology Oncology from the David Geffen School of Medicine at UCLA in 2006. He is the Co-director of the UCLA Gastro-Intestinal Oncology Program and the medical director of the UCLA Colorectal Cancer Center. His research involves a variety of clinical trials in multiple gastrointestinal cancers including pancreas, colon, gastric, and esophageal. Dr. Wainberg’s laboratory-based research involves the testing of novel therapeutics against all gastrointestinal cancers. Currently, he is the recipient of several grants focused on the targeting of cancer stem cells and in molecular classification of GI cancers.

On November 7, 2019 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company"), a novel bioelectric medicine company bringing to market its proprietary CellFX System, reported recent corporate developments and financial results for the three- and nine-month periods ended September 30, 2019 (Press release, Pulse Biosciences, NOV 7, 2019, View Source [SID1234550709]).

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Recent Corporate Developments

The Company continues to work with the Food and Drug Administration ("FDA") on its 510(k) submission for the CellFX System in dermatology. On September 23, 2019 the Company submitted its formal response to the FDA’s April 30, 2019 Additional Information ("AI") Letter request. Upon review of the AI Letter responses, the FDA requested responses to two additional questions and the Company has provided the FDA with draft responses to these questions. Following this, the Company and the FDA mutually agreed to temporarily put the 510(k) submission review on hold to allow sufficient time for the FDA to properly review these remaining responses. The Company continues to work collaboratively with the FDA and believes the review process will be completed during the fourth quarter of 2019 and is continuing to prepare for a potential 510(k) clearance.

In a separate press release today, the Company announced the appointment of Sandra Gardiner as Executive Vice President and Chief Financial Officer effective November 18, 2019. Ms. Gardiner succeeds Brian Dow who has served as our CFO since November 2015.

The Company’s Nano-Pulse Stimulation (NPS) technology was featured prominently during the American Society for Dermatologic Surgery ("ASDS") annual meeting held October 24-27, in Chicago. The following presentations all took place on Thursday October 24:

Investigator Dr. Girish Munavalli presented the latest clinical investigational study data on Sebaceous Hyperplasia (SH) and Warts in two separate oral abstract presentations. The Sebaceous Hyperplasia presentation provided new longer-term data on our original SH clinical study showing durability of efficacy out to at least 12-months with continued high patient satisfaction. The presentation also provided insights into our second SH clinical study including data demonstrating the ability of the CellFX System to clear SH lesions with minimal residual skin effects in a dose dependent manner.

In a second presentation Dr. Munavalli presented data on our wart program, including clinical data and experience from our NPS Wart Feasibility Study followed by early data from our current Warts Pivotal Study. This Pivotal Study allows for multiple NPS treatments to clear the warts so the findings discussed represent an early look at the data.

Investigator Dr. Mark Nestor presented data on the first two patients enrolled in the feasibility acne study on severe back acne. Dr. Nestor reported reductions in acne lesion count of the NPS treated area when compared to control at 90-day follow-up in both patients with very good healing response.

Dr. Tom Rohrer gave an invited presentation in the Emerging Therapies Plenary Session and presented an overview of NPS technology and the various NPS clinical programs to the ASDS audience.

"Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Sebaceous Gland Hyperplasia" with lead author Girish Munavalli, MD, MHS, FACMS, has been published online by the Journal of Dermatologic Surgery. This peer reviewed paper outlines the results, findings and observations from the Company’s clinical study evaluating the safety and efficacy of NPS for the treatment of Sebaceous Hyperplasia and can be found online at: View Source

"Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Seborrheic Keratoses" with lead author George J. Hruza, MD, MBA, FAAD, has been accepted for publication in an upcoming edition of the Journal of Dermatologic Surgery and outlines the results, findings and observations from our clinical study evaluating the safety and efficacy of NPS for the treatment of Seborrheic Keratosis.

The Company has enrolled a total of 35 patients in its CellFX Warts Pivotal Study. The CellFX Warts Pivotal Study is a prospective, non-randomized, multicenter study evaluating the safety and effectiveness of the CellFX System in up to 60 patients with non-genital cutaneous warts. The Company expects to complete enrollment by the end of 2019.

Financial Highlights

Cash, cash equivalents, and investments totaled $34.5 million at September 30, 2019, compared to $59.6 million at December 31, 2018. Cash use totaled $8.1 million for the third quarter of 2019 compared to cash use of $10.2 million for the second quarter of 2019 and $6.8 million for the first quarter of 2019.

Operating expenses for the three-month period ended September 30, 2019 totaled $12.0 million, compared to $10.9 million for the three-month period ended September 30, 2018. Operating expenses for the three-month period ended September 30, 2019 included non-cash stock-based compensation of $2.7 million, compared to non-cash stock-based compensation of $3.4 million for the three-month period ended September 30, 2018.

Operating expenses for the nine-month period ended September 30, 2019 totaled $34.0 million, compared to $28.9 million for the nine-month period ended September 30, 2018. Operating expenses for the nine-month period ended September 30, 2019 included non-cash stock-based compensation of $7.7 million, compared to non-cash stock-based compensation of $10.0 million for the nine-month period ended September 30, 2018.

Net loss for the three-month period ended September 30, 2019 totaled $11.7 million compared to $10.8 million for the three-month period ended September 30, 2018. Net loss for the nine-month period ended September 30, 2019 totaled $33.2 million compared to $28.6 million for the nine-month period ended September 30, 2018.

Conference Call Details

Pulse Biosciences will host an investor call today at 1:30 p.m. PDT / 4:30 p.m. EDT. The telephone dial-in number for the call is (844) 494-0190 (U.S. toll-free) or (508) 637-5580 (international) using Conference ID 7381116. Listeners will also be able to access the call via webcast available on the Investors section of the Company’s website at www.PulseBiosciences.com.

On November 7, 2019 Aduro Biotech, Inc. (NASDAQ: ADRO), a clinical-stage biopharmaceutical company focused on developing therapies targeting the Stimulator of Interferon Genes (STING) and A Proliferation Inducing Ligand (APRIL) pathways for the treatment of cancer, autoimmune and inflammatory diseases, reported financial results for the third quarter ended September 30, 2019 (Press release, Aduro Biotech, NOV 7, 2019, View Source [SID1234550708]).

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Cash, cash equivalents and short term and long term marketable securities totaled $235.4 million at September 30, 2019, compared to $277.9 million at December 31, 2018.

"We remain highly focused on the development of our STING and APRIL programs, with the initiation of our Phase 2 study of ADU-S100 in combination with pembrolizumab in head and neck squamous cell carcinoma and continued progress of our Phase 1 study of BION-1301 in IgA nephropathy," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "Our strong cash position of $235.4 million at the end of the third quarter enables us to continue investing in our STING and APRIL programs with the ultimate goal of providing therapeutic benefit to patients."

Recent Highlights

Cleared four healthy volunteer dose cohorts in the single ascending dose portion and one healthy volunteer dose cohort in the multiple ascending dose portion of the Phase 1 clinical trial of BION-1301 for the treatment of IgA nephropathy.

First patient dosed in Phase 2 clinical trial of ADU-S100 (MIW815) in combination with Keytruda (pembrolizumab), an approved anti-PD-1 antibody, as a first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma.

Financial Results

Revenue – Revenue was $4.8 million for the third quarter of 2019 and $13.6 million for the nine months ended September 30, 2019, compared to $3.1 million and $12.3 million, respectively, for the same periods in 2018. The increase in revenue for the quarter and the year to date was primarily due to ratable recognition of the upfront payment received from Eli Lilly in the first quarter of 2019.

Expenses –

Research and development expenses were $15.5 million for the third quarter of 2019 and $51.9 million for the nine months ended September 30, 2019, compared to $18.7 million and $58.2 million, respectively, for the same periods in 2018. The quarter and year to date costs decreased primarily due our strategic reset in January 2019, which resulted in reduced headcount and stock-based compensation expense. The reset also resulted in reduced spending towards deprioritized programs partially offset by higher spending towards our STING and APRIL programs.

General and administrative expenses were $8.7 million for the third quarter of 2019 and $25.8 million for the nine months ended September 30, 2019, compared to $9.1 million and $27.0 million, respectively, for the same periods in 2018. The quarter and year to date costs decreased primarily due to our strategic reset in January 2019, which resulted in reduced headcount and stock-based compensation expense.

Loss on impairment of intangible assets was $5.0 million for the third quarter of 2019. This expense was recorded due to the discontinuation of one of our acquired early research programs.

Net Loss – Net loss for the third quarter of 2019 was $21.0 million or $0.26 per share and $63.0 million or $0.79 per share for the nine months ended September 30, 2019, compared to net loss of $23.1 million or $0.29 per share and $69.0 million or $0.88 per share, respectively, for the same periods in 2018.