On May 7, 2020 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including colorectal cancer, prostate cancer and leukemia, reported company highlights and financial results for the first quarter ended March 31, 2020 (Press release, Trovagene, MAY 7, 2020, View Source [SID1234557390]). The company is issuing this press release in lieu of conducting a conference call.

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"We are pleased with the promising data we are seeing in all three of our ongoing clinical programs and the continued support from our clinical trial sites and investigators," said Dr. Thomas Adams, Executive Chairman of Trovagene. "We began the year with an update from our trial in KRAS-mutated metastatic colorectal cancer (mCRC) at the ASCO (Free ASCO Whitepaper)-GI conference, and most recently presented new data from this trial in an oral presentation at the American Association for Clinical Research (AACR) (Free AACR Whitepaper) annual meeting, demonstrating consistent tumor shrinkage, across KRAS mutations, and progression-free survival exceeding that of current standard-of-care. Treatment with onvansertib has been so successful in KRAS-mutated mCRC, an indication which until now had a response rate of only 4% and a very poor prognosis, that one of the patients in our trial went on to have successful curative surgery, an unlikely event in this patient population. We also continue to see the safety and efficacy of onvansertib in our two Phase 2 trials; Zytiga-resistant castration-resistant prostate cancer (mCRPC) and relapsed/refractory acute myeloid leukemia (AML), with additional data readouts from all three trials anticipated throughout 2020."

The Company has advanced its business to-date in 2020, with the following activities and milestone achievements:

Announced company name change from Trovagene, Inc. to Cardiff Oncology, Inc. and appointment of Mark Erlander, PhD, as Chief Executive Officer, with an effective date of Friday, May 8, 2020
On May 6, 2020, we announced a change in our Company name change from Trovagene, Inc. to Cardiff Oncology, Inc., and a change in leadership with Mark Erlander, PhD, assuming the role of Chief Executive Officer. Thomas Adams, PhD, our current Chairman and CEO will transition his role to Executive Chairman. Our new name reflects the Company’s mission and commitment to turning the tide on cancer by advancing the development of onvansertib, our first-in-class, third-generation, oral and highly-selective Polo-like Kinase 1 (PLK1) inhibitor, across multiple cancer types. Our company name and leadership changes will be effective as of Friday, May 8, 2020. In connection with the new corporate name, the Company’s Nasdaq ticker symbol will change to ‘CRDF’ and will be effective at the open of the market on Friday, May 8, 2020.

Announced presentation of data from clinical trial in KRAS-mutated metastatic colorectal cancer demonstrating consistent tumor regression across KRAS mutation subtypes and durable response
On April 28, 2020, we announced new positive results from our ongoing Phase 1b/2 clinical trial of onvansertib in combination with FOLFIRI and Avastin (bevacizumab) for second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC). The data were featured in a virtual oral presentation, delivered by Dr. Afsaneh Barzi, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) conference on Monday, April 27, 2020. The ongoing Phase 1b/2 trial has enrolled 12 patients with 88% response in 7 of 8 evaluable patients to-date: 3 patients exhibiting a partial response (PR), and 4 patients with stable disease (SD). Data show median progression-free survival (PFS) of at least 6.5 months with 6 patients continuing on treatment to-date, and one patient having gone on to successful curative surgery. The level of KRAS mutations in blood during treatment is the biomarker used in this trial, with a decrease to non-detectable level in cycle one of treatment being predictive of future tumor regression and response.

Announced expansion of Board of Directors with the addition of three industry leaders
On April 22, 2020, we announced the election of three new independent Directors to our Board of Directors; Dr. James Armitage, Ms. Lâle White and Dr. Gary Pace. Each new Director brings extensive and relevant experience to the Company and will provide valuable perspective and meaningful impact as we enhance value to our shareholders.

Announced presentation of Phase 2 data demonstrating the ability of onvansertib to overcome Zytiga-resistance and provide clinical benefit for mCRPC patients
On February 13, 2020, we announced the presentation of positive data from our ongoing Phase 2 trial of onvansertib in combination with Zytiga for the treatment of patients with Zytiga-resistant mCRPC. The data demonstrated the efficacy of onvansertib in Zytiga-resistant mCRPC across known androgen receptor resistance mechanisms. Additionally, the appearance of an onvansertib-induced decrease in circulating tumor cells (CTCs) was established as a surrogate for efficacy, and was associated with greater progression-free survival in mCRPC patients.

Announced that Trovagene received approximately $1.45 million from exercise of warrants
On January 29, 2020, we announced that the Company received approximately $1.45 million in proceeds from holders exercising common stock purchase warrants at an exercise price of $1.56 per share. The warrants were issued as part of the units sold to certain institutional investors in October, 2019. Additionally, we received two separate individual investments of approximately $1.0 million each in March and April, respectively, for a total of approximately $3.45 million to-date in 2020.

First Quarter 2020 Financial Results

Total operating expenses were approximately $4.2 million for the three months ended March 31, 2020, an increase of $0.2 million from $4.0 million for the same period in 2019. The increase in operating expenses is attributed to advancing the onvansertib clinical development programs.

Net cash used in operating activities in the first quarter of 2020 and the first quarter of 2019 was $3.4 million.

Research and development expenses increased by approximately $0.1 million to $2.7 million for the three months ended March 31, 2020 from $2.6 million for the same period in 2019. The increase in research and development expenses was primarily due to costs associated with advancing clinical studies related to the development of our drug candidate, onvansertib. We expect increases in research and development costs to continue as we advance our onvansertib clinical development programs in mCRC, mCRPC and AML.

Selling, general and administrative expenses increased by approximately $0.1 million to $1.5 million for the three months ended March 31, 2020 from $1.4 million for the same period in 2019. The increase is primarily due to an increase in facilities and other costs, and outside services.

The weighted average basic and diluted shares of common stock outstanding used to calculate per share results for the three months ended March 31, 2020 was 9.9 million.

As of March 31, 2020, Trovagene had approximately $9.3 million of cash and cash equivalents.

On May 7, 2020 Protagonist Therapeutics, Inc. (Nasdaq:PTGX) reported its financial results for the first quarter ended March 31, 2020, and provided an update on clinical development programs (Press release, Protagonist, MAY 7, 2020, View Source [SID1234557389]).

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"Based on the highly promising and consistent clinical responses achieved to date, we are pleased to announce polycythemia vera as the first indication for a pivotal study of PTG-300," commented Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. "With an orphan drug development regulatory path forward, we are focused on rapidly advancing PTG-300 as a first-in-class non-cytoreductive hepcidin hormone mimetic agent for this indication with significant unmet need. With a highly focused development effort forward with PTG-300 for polycythemia vera, and deferring PN-943 Phase 2 initiation due to the current COVID-19 environment, we have reduced our operational expenditures and now have an additional six months of cash runway estimated to extend through mid-2022."

Product Development Update

PTG-300: Injectable Hepcidin Mimetic

Initial Phase 2 results in patients with polycythemia vera from an ongoing study demonstrated that treatment with PTG-300 at individualized doses ranging from 10 mg to 80 mg for up to 28 weeks controlled hematocrit levels. All patients were phlebotomy free (except a single phlebotomy due to an unintended dose interruption in a patient who remains on study). Administration of PTG-300 was well tolerated and the safety profile was generally similar with results of prior studies, with injection site reactions and bruise as the only adverse events related to or possibly related to treatment. Results are available as of the May 1, 2020, cutoff date.
The results of the PTG-300 beta-thalassemia Phase 2 study will be presented at an upcoming medical conference in the second quarter of 2020.
Protagonist will redirect the majority of its PTG-300 efforts to the polycythemia vera indication, while also continuing its exploration of PTG-300 in hereditary hemochromatosis. The Company is discontinuing clinical development for PTG-300 in beta-thalassemia and myelodysplastic syndromes.
PTG-200 (JNJ-67864238): Oral IL-23 Receptor Antagonist for Inflammatory Bowel Disease

In collaboration with Janssen Biotech, we initiated a Phase 2 global study for PTG-200 (or JNJ-67864238) in moderate-to-severe Crohn’s disease in the fourth quarter of 2019. Because of the global COVID-19 pandemic, guidance has been currently suspended on a timeline for study completion.
PN-943: Oral Alpha-4-Beta-7 Integrin Antagonist for Inflammatory Bowel Disease

A Phase 2 study of PN-943 in approximately 150 patients with moderate-to-severe ulcerative colitis is currently planned.
In light of the global COVID-19 pandemic, Protagonist continues to review all aspects of the planned Phase 2 study and is currently suspending guidance on a timeline for study initiation. The Company is maintaining readiness to initiate the study as soon as conditions allow for safe accrual of subjects for the global study.
Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2020, were $117.5 million. Due to the focusing of efforts on polycythemia vera and the delay in PN-943 trial initiation caused by the ongoing global COVID-19 pandemic and a related internal reorganization, the company believes its adjusted operating plans now provide sufficient financial resources from its cash, cash equivalents, marketable securities and access to its debt facility to fund its currently planned operating and capital expenditures through mid-2022. The company will continue to monitor events closely and may further adjust its operating plans as warranted.
License and Collaboration Revenue: License and collaboration revenue of $3.6 million for the first quarter of 2020 increased in comparison to $1.6 million reported for the same period of 2019. License and collaboration revenue is generally earned over time as services are provided under the collaboration.
Research and Development ("R&D") Expenses: R&D expenses for the first quarter 2020 were $18.8 million as compared to $12.4 million for the same period of 2019. The increase was primarily due to increased clinical development costs related to PTG-300, PN-943 and our IL-23 receptor antagonist collaboration with Janssen Biotech to develop PTG-200 and the related research collaboration efforts.
General and Administrative ("G&A") Expenses: G&A expenses for the first quarter 2020 were $4.6 million, as compared to $3.8 million for the same period of 2019. The increase was primarily due to increases in salaries, employee-related expenses and professional services to support the growth in our operations.
Net Loss: The first quarter 2020 net loss was $20.1 million, or a net loss of $0.72 per share, as compared to a net loss of $14.1 million, or a net loss of $0.58 per share, for the same period of 2019.
Conference Call and Webcast Information

Protagonist will host a conference call at 5 p.m. EDT / 2 p.m. PDT today to provide a corporate update. Ronald Hoffman, M.D., Director of the Myeloproliferative Diseases Program at The Icahn School of Medicine at Mount Sinai, will join the call to present initial results for PTG-300 in polycythemia vera. To access the live call, dial 1-844-515-9178 (U.S./Canada) or 1-614-999-9313 (international) and refer to conference ID number 4597494. A live and archived webcast will also be accessible in the Investors section of the Company’s website at www.protagonist-inc.com.

On May 7, 2020 Precision Optics Corporation, Inc. (OTCQB: PEYE) (the "Company") reported that it has scheduled a conference call to discuss third quarter of fiscal 2020 financial results on Thursday, May 14, 2020 at 5:00pm ET (Press release, Precision Optics, MAY 7, 2020, View Source [SID1234557388]).

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The Company intends to release its financial results and to file its 10-Q after the close of the market on May 14, 2020 followed by the conference call.

Conference Call Details

Date and Time: Thursday, May 14, 2020 at 5:00pm ET

Call-in Information: Interested parties can access the conference call by dialing (844) 735-3662 or (412) 317-5705.

Live Webcast Information: Interested parties can access the conference call via a live Internet webcast, which is available at View Source

Replay: A teleconference replay of the call will be available until May 21, 2020 at (877) 344-7529 or (412) 317-0088, confirmation # 10143454. A webcast replay will be available at View Source

On May 7, 2020 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX, TSX-V: EPI), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported financial results for the fiscal second quarter ended March 31, 2020 (Press release, ESSA, MAY 7, 2020, View Source [SID1234557387]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

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"This past quarter has seen ESSA achieve a significant milestone as we filed the IND for EPI-7386 on time, and subsequently received allowance from the FDA to proceed with the Phase I clinical trial of EPI-7386," stated David Parkinson, MD, President and CEO of ESSA. Dr. Parkinson continued, "We are currently working with clinical sites in the US and Canada so we can begin enrollment of patients as soon as possible, ensuring compliance with COVID-19 risk management guidance as provided by the FDA."

Recent Corporate Highlights

The Investigational New Drug ("IND") application for EPI-7386 was filed and accepted by the Food and Drug Administration ("FDA"), and a clinical trial application ("CTA") was subsequently filed with Health Canada. The clinical trial is expected to enroll approximately 18 patients at multiple medical institutions in a standard 3+3 trial design with an approximate 10 additional patients enrolled in the dose expansion cohort.
Entered into an Open Market Sale Agreement (the "ATM Sales Agreement") with Jefferies LLC, effective as of April 13, 2020. Under the ATM Sales Agreement, ESSA may sell its common shares in the capital of the Company from time to time for up to US$35.0 million in aggregate sales proceeds in "at-the-market" transactions.
The Company will present posters with preclinical data on EPI-7386 at both the American Urological Association Annual Meeting to be held virtually on May 18, 2020 and the AACR (Free AACR Whitepaper) Virtual Annual Meeting II held from June 22-24th. The poster presentations will include new gene expression data for EPI-7386, enzalutamide and the combination of the two in prostate cancer models.
The ESSA management team will participate in Jefferies Virtual Healthcare Conference from June 2-4, 2020.
Summary Financial Results

Net Income (Loss). ESSA recorded a net loss of $9.4 million ($0.45 loss per common share based on 20,819,572 weighted average common shares outstanding) for the quarter ended March 31, 2020, compared to a net loss of $3.4 million ($0.54 loss per common share based on 6,311,098 weighted average common shares outstanding) for the quarter ended March 31, 2019. This included non-cash share-based payments of $3.6M for the quarter ended March 31, 2020 compared to $316,407 for the quarter ended March 31, 2019, recognized for stock options granted and vesting.

Research and Development ("R&D") expenditures. R&D expenditures for the quarter ended March 31, 2020 were $4.6 million compared to $1.5 million for the quarter ended March 31, 2019. The increase in R&D expenditures for the quarter were primarily related to preparing the IND application for EPI-7386, preparatory clinical costs, manufacturing and chemistry costs, and non-cash costs related to share-based payments ($1.03M for quarter ending March 31, 2020 compared to $92,851 for quarter ended March 31, 2019). R&D costs in the comparative period were primarily related to preclinical research of the Company’s next-generation aniten compounds.

General and administration ("G&A") expenditures. G&A expenditures for the quarter ended March 31, 2020 were $4.9 million compared to $1.8 million for the quarter ended March 31, 2019. The increase in the quarter is primarily due to non-cash share-based payments. ($2.55M for the quarter ending March 31, 2020 compared to $223,556 for the quarter ending March 31, 2019.)
Liquidity and Outstanding Share Capital

Cash on hand at March 31, 2020 was $39.9 million, with working capital of $39.7 million, reflecting the aggregate gross proceeds of the August 2019 financing of $36 million and the acquisition of Realm Therapeutics plc which provided the Company with $22.2 million in cash, less operating expenses in the intervening period.

As of March 31, 2020, the Company had 20,824,339 common shares issued and outstanding.

In addition, as of March 31, 2020 there were 12,331,127 common shares issuable upon the exercise of warrants and broker warrants. This includes 11,919,404 prefunded warrants at an exercise price of $0.0001 that were issued in lieu of common shares in the August 2019 financing, and 411,723 other warrants at a weighted average exercise price of $38.93. There are 5,310,000 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $3.41 per common share.

On May 7, 2020 Bridge Biotherapeutics Inc.(KOSDAQ: 288330), a clinical stage biotech company headquartered in Seongnam, Republic of Korea, reported that the Investigational New Drug (IND) application of BBT-176 submitted to South Korea’s Ministry of Food and Drug Safety (MFDS) was officially cleared on May 7th (Press release, BridgeBio, MAY 7, 2020, View Source [SID1234557364]).

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BBT-176, a novel epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) is designed to inhibit the signaling pathway of EGFR with C797S mutations, which arise as Tagrisso (osimertinib) resistant mutations following Tagrisso treatment in non-small cell lung cancer (NSCLC). The mutation results in a cysteine to serine change in the 797 position of the kinase domain sequence of the EGFR. During pre-clinical studies, BBT-176 exhibited strong anti-tumor efficacy in C797S triple mutations. Additionally, BBT-176 displayed markedly enhanced efficacy when combined with anti-EGFR antibodies.

On IND clearance in South Korea, Bridge Biotherapeutics plans to initiate a dose escalation study as the first part of the phase I/II study in Korea to find the maximum tolerable dose (MTD), the recommended phase 2 dose (RP2D) and to observe safety, tolerability and the anti-tumor efficacy of BBT-176 in a group of patients with advanced NSCLC. After completing the dose escalation study, a dose expansion study will be initiated in both the U.S. and South Korea. During this study, the company will assess the safety, tolerability and efficacy along with the RP2D of the drug candidate.

Under the study protocol, approximately 90 patients are expected to be included in the Phase I/II study of BBT-176. The company will also observe detailed anti-tumor efficacy in the combination therapy of BBT-176 with anti-EGFR antibodies.

"We are greatly encouraged by the IND clearance of BBT-176 in South Korea," and "Bridge will continue to focus on bringing new treatment options for patients in need of a novel NSCLC therapy," said James Lee, CEO of Bridge Biotherapeutics.

BBT-176 was discovered by the Korea Research Institute of Chemical Technology (KRICT), a Korean government research institute. The global exclusive rights for further development was licensed to Bridge Biotherapeutics in December 2018. Since the US FDA cleared the IND application of BBT-176 in January 2020, Bridge Biotherapeutics has been in continuous discussions with global and local pharmaceuticals and biotech companies regarding potential business alliance opportunities.

Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths. It is divided into NSCLC and small cell lung cancer (SCLC) and NSCLC accounts for approximately 85% of all lung cancers. Overall, across the 8 major countries including the U.S., 5 EU countries, China and Japan, the total NSCLC population as of 2015 is assumed 2 million and the incidence of NSCLC is expected to increase at an annual growth rate of 3.1% from 2015 to 2025.[i]