On November 13, 2019 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), a leading biotechnology company developing novel products for life science markets, reported its financial results for the third quarter, ending September 30, 2019 (Press release, Evogene LTD, NOV 13, 2019, View Source [SID1234551232]).

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Ofer Haviv, Evogene’s President and CEO, stated, "During the third quarter of 2019, we reached an important milestone with the investment in our subsidiary, Lavie Bio, by Corteva. This investment represents the first major, third party, financial and commercial implementation of our corporate strategy, as we outlined in our 2019 letter to the shareholders. The core of this strategy is to create shareholder value within Evogene by leveraging our unique Computational Predictive Biology ‘CPB’ platform through specific market-focused subsidiaries where the platform provides a significant competitive advantage. As our subsidiaries gain traction and begin to attract investor interest, the intrinsic value of Evogene will continue to increase."

"Looking ahead, we will continue to provide our subsidiaries with exclusive access to our unique ‘CPB’ technology platform, which accelerates the product pipeline development within each subsidiary. In addition, Evogene will continue to leverage its strong cash position to provide financial support to each subsidiary until it reaches the point whereby its progress and assets warrant an attractive valuation. At such a stage, as demonstrated by the recent Lavie Bio investment, Evogene intends to bring in value-adding and strategic partners, while still remaining a major shareholder." Mr. Haviv concluded

Recent Highlights:

AgPlenus:

Expansion of its herbicide pipeline with an additional two chemical families, to include a total of five chemical families with validated new modes-of-action.
In its insecticide program, the first molecules resulting from discovery efforts are being synthesized and are expected to enter insect screening within the next few months.
Biomica:

Achievement of positive preliminary results in animal studies in its immuno-oncology program demonstrating improved anti-tumor activity.
Advancement to pre-clinical studies in its Inflammatory Bowel Disease (IBD) Program.
Initiation of a collaboration with the Weizmann Institute of Science to develop a selective treatment against antibiotic resistant bacteria, in-licensing IP and know-how generated by Professor Ada E. Yonath, Nobel Prize winner in Chemistry, who will advise Biomica on the program.
Canonic:

Initiation of the cultivation and breeding of cannabis varieties with unique genomic profiles for the development of medical cannabis products, following import of a genetically diverse cannabis seed collection, establishment of specialized R&D facilities, and receipt of regulatory approval from the Israeli Medical Cannabis Agency (IMCA).
Casterra:

Following semi-commercial trials in both Brazil and Argentina, Casterra has decided to focus on the Brazilian market, which has a well-developed castor market with several castor oil manufacturers providing a substantial demand for castor grain.
Lavie Bio:

Corteva Agriscience, a major US agricultural chemical and seed company, announced its investment in Lavie Bio, Evogene’s ag-biologicals subsidiary. The investment included $10 million in equity and the transfer of Corteva’s holdings in Taxon Biosciences, a wholly owned subsidiary, following which Corteva holds approximately 30% of Lavie Bio, and Evogene, approximately 70%.
Progress in its product development within its bio-fungicide pipeline for fruit & vegetables, reaching a significant milestone. In this program, Lavie Bio has moved forward to the advanced development stage following successful vineyard trials in Europe.
Completion of the discovery stage and establishment of a pipeline targeting pests in corn & soybean.
Evogene has initiated a revised policy regarding the filing of announcements made by its subsidiaries. All of such announcements will continue to be distributed by press release to the wire services and uploaded to Evogene’s website. However, Evogene will only re-file the announcement if the news is considered to have material impact, not just for such subsidiary, but for all of Evogene as a whole, by reporting it on an Evogene Form 6-K to the US Securities and Exchange Commission’s EDGAR platform and making a corresponding report to the Israeli Securities Authority’s MAGNA platform. Evogene encourages investors to follow the development of its subsidiaries via the Evogene website and mailing list.

Consolidated financial results for the period ending September 30, 2019:

Cash position: As of September 30, 2019, Evogene had $52.1 million in consolidated net cash, short-term bank deposits and marketable securities. The Company cash usage amounted to $12.3 million during the first nine months of 2019 and $3.7 million during the third quarter of 2019. Evogene’s consolidated cash includes a $10 million investment in its subsidiary, Lavie Bio, received from Corteva during the third quarter of 2019.

The Company continues to estimate that its cash usage for the whole of 2019 will be in the range of $16 to $18 million dollars. During the fourth quarter of 2019, the Company made the payment of the directors’ and officers’ liability insurance policies, which was substantially higher than in previous years due to changes in D&O insurance market conditions, in accordance with the approval of the general shareholders on September 26, 2019

Evogene’s consolidated cash use is mostly appropriated to its subsidiaries, primarily Lavie Bio, AgPlenus, and Biomica, with funds also used for the establishment of infrastructure and greenhouses for Canonic.

Evogene does not have bank debt.

The Company intends to provide information with regard to its expected burn rate for 2020 in its press release for the fourth quarter of 2019.

Revenues for the third quarter of 2019, were $0.1 million versus $0.4 million in the same period last year. Revenues primarily consist of third-party research and development payments. These revenues represent R&D cost reimbursement and milestone payments under our various collaboration agreements. The majority of these agreements also provide for royalties or other forms of revenue sharing from successfully developed products.

Gross profit for the third quarter of 2019 was $16 thousand in comparison to $91 thousand in the third quarter of 2018.

R&D expenses for the third quarter of 2019 were $3.6 million in comparison to $3.9 million in the third quarter of 2018.

R&D expenses mostly represent product development activities of the Company and its subsidiaries, which include computational work, lab & greenhouse assays, field-trials and pre-clinical studies provided by third parties. Evogene’s consolidated R&D expenses were mostly attributed to its subsidiaries, primarily Lavie Bio, AgPlenus, and Biomica.

Operating loss for the third quarter of 2019 was $4.9 million in comparison to $5.1 million in the third quarter of 2018.

Net financing income for the third quarter of 2019 was $0.4 million in comparison to net financing income of $0.3 million in the third quarter of 2018.

Loss for the third quarter of 2019 was $4.5 million in comparison to a loss of $4.8 million during third quarter of 2018.

Conference Call & Webcast Details:
Date: November 13th, 2019
Time: 9:00am EST; 16:00 Israel time
Dial-in: 1-888-668-9141 toll free from the United States, or +972-3-918-0609 internationally
Webcast: Available at www.evogene.com.

Replay Information: A replay of the conference call will be available approximately three hours following the completion of the call.

To access the replay, please dial 1-888-326-9310 toll free from the United States, or +972-3-925-5900 internationally. The replay will be accessible through November 15, 2019, and an archive of the webcast will be available on the Company’s website through November 28, 2019.

On November 13, 2019 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported that Dean Schorno, the company’s chief financial officer, is scheduled to present a company overview at the Jefferies 2019 London Healthcare Conference on Thursday, November 21, 2019 at 4:40pm GMT (Press release, Rigel, NOV 13, 2019, View Source [SID1234551231]).

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To access the live webcast of the presentation or the subsequent archived recording, log on to www.rigel.com. Please connect to Rigel’s website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.

On November 13, 2019 Skyhawk Therapeutics, Inc. (Skyhawk), reported that it has reached a second global strategic collaboration agreement with a subsidiary of Celgene Corporation (NASDAQ: CELG ) (Press release, Skyhawk Therapeutics, NOV 13, 2019, View Source [SID1234551230]). This new agreement is made after the June 2018 collaboration between the two companies and focuses on relevant targets in the field of autoimmune disorders, oncology and immunooncology, thus revalidating the patented SkySTAR TM technology platformfrom Skyhawk. The scope of this collaboration allows the parties to systematically examine a series of targets that have been clinically validated or that are associated at a high level with the genetic basis of the disease, but that have been considered resistant to drugs by conventional based treatments of small molecules.

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Under the collaboration agreement, Skyhawk grants Celgene the option to grant exclusive licenses of intellectual property rights worldwide to pharmacological candidates discovered and developed under the auspices of the collaboration agreement and aimed at the targets of the program. In the event that Celgene decides to make use of this option, Celgene will be responsible for its development and commercialization.

"Our impressive advances to date in relation to the targets that our collaboration that took place in 2018 includes have led Celgene to sign this new agreement focused on targets that go beyond neurology," said Bill Haney , co-founder and CEO from Skyhawk Therapeutics. "This is further proof of the capacity of our SkySTAR TM technology platformto quickly identify niches where to apply the drugs and the unique chemical matter to correct the incorrect splicing of RNA, and that can lead to new treatment options for patients. We look forward to seeing the progress of the programs in line with this new collaboration and the potential to offer new treatment options to patients with unmet medical needs. "

"The rapid and remarkable progress made by the Skyhawk team shows us the exclusive advantages of the SkySTAR TM platform and has led us to expand our relationship. We see the Skyhawk platform as a revolutionary and key technology that supports the portfolio of disease treatments autoimmune, oncological and immuno-oncology of the company that we are today and that which we have set ourselves to become, "said Rupert Vessey , MA, BM, B.Ch., FRCP, D.Phil., president of Research and Initial Development of Celgene Corporation

On November 13, 2019 Lipocine Inc. (NASDAQ:LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported the launch of a public offering of units consisting of shares of its common stock (or pre-funded warrants) and warrants to purchase its common stock (Press release, Lipocine, NOV 13, 2019, View Source [SID1234551229]). The shares of common stock (or pre-funded warrants) and warrants comprising the units are immediately separable and will be issued separately, but will be purchased together. The offering is being conducted on a best-efforts basis and is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

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Roth Capital Partners is acting as sole agent for the public offering.

The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-220942) (including a prospectus) previously filed with and declared effective by the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the offering will be filed with the SEC.

A copy of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may be obtained, when available, by contacting Roth Capital Partners, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660, (800) 678-9147. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus will also be available free of charge on the website of the SEC at www.sec.gov.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, nor will there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On November 13, 2019 Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of cancer patients, reported financial results for the three and nine months ended September 30, 2019, and provides an update on its business progress (Press release, Biocept, NOV 13, 2019, View Source [SID1234551228]).

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"We continued to deliver strong growth during the third quarter of 2019 with revenues reaching a record $1.5 million, up 101% over the same period in the prior year and up 28% over the second quarter of this year," said Michael Nall, President and CEO of Biocept. "Our momentum was driven by a 66% year-over-year increase in the number of commercial samples received, as we focus on segments of the liquid biopsy market where our Target Selector technologies and testing platform can help the most patients, namely patients with lung, prostate and breast cancers. In addition, we continue to work to control expenses, which has moved us closer to gross margin positive. We are focused on continued growth in commercial volume and improvement in gross margin percent through operational efficiencies.

"Testing for lung cancer continued to be among the largest contributors to commercial volume due to the difficulties in securing lung tissue samples from this patient population," he added. "We also continue to gain traction in the uro-oncology market where our blood-based testing is used by urologists to monitor patients with rising prostate-specific antigen (PSA) levels as well as in the post-surgery setting to identify patients at risk for cancer recurrence. We are seeing increasing reorders from the physicians and practices who began using our Target Selector products earlier this year, while establishing relationships with additional urologists and urology practice groups during the third quarter. We expect continued growth in this business segment.

"Our Target Selector testing for breast cancer was also a key contributor to commercial volume growth during the quarter. Clinicians treating patients with breast cancer are utilizing our blood-based assays for initial profiling of biomarkers to ensure that critical biomarkers are not missed with the original tissue biopsy as well as to re-profile patients who have cancer recurrence in order to determine the most appropriate treatment plan for each patient," Nall said.

Review of Third Quarter and Recent Highlights

Commercial Agreements

Announced an agreement with Beacon Laboratory Benefit Solutions designating Biocept as a BeaconLBS Lab-of-Choice. Beacon Laboratory is a nationally recognized provider of laboratory benefit management technology solutions to U.S.-based health and managed care companies. This designation increases patient access to Biocept’s liquid biopsy testing platforms.
Regulatory Approval

Obtained CE IVD Marks for the CEE-Sure Blood Collection Tube and the CEE-Sure Sample Collection Shipping Kit in Europe. These CE Marks confirm that Biocept’s CEE-Sure products, which are specifically designed to collect and transport blood and other liquid biopsy specimens, meet the requirements of the European In-Vitro Diagnostic Devices Directive. This allows Biocept to commercialize its tubes and collection/shipping kits throughout the European Union and other CE Mark geographies.
Industry Conferences and Study Results

Announced the presentation of six posters at the 2019 Association for Molecular Pathology (AMP) Annual Meeting featuring clinical data highlighting Target Selector tests and kits. The content of these posters is expected to be published in a future issue of The Journal of Molecular Diagnostics.
Presented data at the 2019 IASLC World Conference on Lung Cancer highlighting the ability of Biocept’s circulating tumor DNA (ctDNA) assays to consistently detect actionable biomarkers from the blood of patients diagnosed with lung cancer at a mutant allele frequency as low as 0.01%. The poster featured clinical experience data from more than 1,400 blood samples drawn from patients diagnosed with non-small cell lung cancer, and collected and shipped using the Company’s CEE-Sure Blood Collection Tubes.
Peer-reviewed Journal Publications

Announced publication of an article in the peer-reviewed journal PLOS ONE featuring analytical validation results demonstrating the ultra-sensitive detection of Target Selector testing for EGFR, BRAF and KRAS mutations in plasma ctDNA. These tests can be performed in the Company’s CLIA laboratory with a commercial turnaround time of only three to four days.
Intellectual Property

Awarded U.S., Canadian and European patents covering antibody and microchannel technology and enhanced detection of cancer cells. These new patents further expand Biocept’s intellectual property estate for capturing and detecting rare cells of interest, including CTCs to aid in the management of patients with cancer.
Granted a South Korean patent covering the Target Selector oncogene mutation enrichment and detection platform for proprietary Switch-Blocker technology that is core to Target Selector assays for molecular analysis using real-time PCR, Sanger sequencing and next-generation sequencing.
Ended the period with 36 issued patents globally for Biocept’s highly sensitive method of detecting cancer biomarkers.
Third Quarter Financial Results

Revenues for the third quarter of 2019 were $1.5 million, a 101% increase from $762,000 for the third quarter of 2018. Revenues for the third quarter of 2019 included $1.4 million in commercial test revenue, $40,000 in development services test revenue and $60,000 in revenue for Target Selector RUO kits, which were commercially launched in early 2019, and CEE-Sure blood collection tubes. Revenues for the third quarter of 2018 included $698,000 in commercial test revenues and $64,000 in development services test revenues.

Biocept accessioned 1,189 commercial samples during the third quarter of 2019, a 66% increase from the 717 commercial samples accessioned during the third quarter of 2018. The Company accessioned 1,332 billable samples in the third quarter of 2019, a 52% increase from 878 billable samples for the third quarter of 2018.

Cost of revenues for the third quarter of 2019 was $2.8 million, compared with $2.5 million for the third quarter of 2018. Cost of revenues for the third quarter of 2019 increased 14% while volume increased by nearly 50% as the Company continued to leverage its fixed costs.

Research and development (R&D) expenses for the third quarter of 2019 were $1.2 million, compared with $1.1 million for the third quarter of 2018, with the increase primarily due to an increase in materials used for developing and validating new assays. General and administrative (G&A) expenses for the third quarter of 2019 were $1.7 million, a decrease from $1.8 million during the third quarter of 2018 as the Company continued its cost-containment program. Sales and marketing (S&M) expenses for the third quarter of 2019 were $1.5 million, compared with $1.4 million for the third quarter of 2018, with the increase primarily attributed to commissions paid for higher volume and revenue.

The third quarter of 2018 included a non-cash deemed dividend of $0.6 million for the repricing of adjustable warrants. There was no comparable charge in the third quarter of 2019.

The net loss attributable to common shareholders for the third quarter of 2019 was $5.7 million, or $0.25 per share on 23.0 million weighted-average shares outstanding. The net loss attributable to common shareholders for the third quarter of 2018 was $6.7 million, or $2.42 per share on 2.8 million weighted-average shares outstanding. The Company completed a 1-for-30 reverse stock split of its common stock in July 2018.

Nine Month Financial Results

Revenues for the first nine months of 2019 were $3.7 million, a 57% increase from $2.4 million for the first nine months of 2018, and included $3.5 million in commercial test revenues, $130,000 in development services test revenues, and $90,000 in revenues for Target Selector RUO kits and CEE-Sure blood collection tubes.

Total costs and expenses for the first nine months of 2019 were $21.2 million, and included cost of revenues of $8.1 million, R&D expenses of $3.5 million, G&A expenses of $5.1 million and S&M expenses of $4.5 million.

Other expense for the first nine months of 2019 of $2.0 million consisted of non-cash warrant inducement expenses associated with recognizing the fair value of the inducement warrants issued in May 2019 of $1.8 million and $190,000 of interest expense. This compares with other expense of $240,000 for the first nine months of 2018 related to interest expense. The nine months ended September 30, 2019 included a non-cash deemed dividend of $0.1 million for the repricing of adjustable warrants, compared with a non-cash deemed dividend of $0.6 million for the repricing of adjustable warrants during the nine months ended September 30, 2018.

The net loss attributable to common shareholders for the first nine months of 2019 was $19.5 million, or $1.10 per share on 17.8 million weighted-average shares outstanding. This compares with a net loss attributable to common shareholders for the first nine months of 2018 of $19.2 million, or $8.26 per share on 2.3 million weighted-average shares outstanding. The Company completed a 1-for-30 reverse stock split of its common stock in July 2018.

Biocept reported cash and cash equivalents as of September 30, 2019 of $6.5 million, compared with $3.4 million as of December 31, 2018. The increase was due to $17.0 million in net proceeds from equity capital raises conducted in the first quarter of 2019, and $4.9 million from the exercise of common stock warrants exercised year-to-date in 2019.

Conference Call and Webcast

Biocept will hold a conference call today at 4:30 p.m. Eastern time to discuss these results and answer questions. The conference call can be accessed by dialing (855) 656-0927 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4109 for other international callers. A live webcast of the conference call will be available on the investor relations page of the company’s website at http://ir.biocept.com/events.cfm. A replay of the webcast will be available for 90 days.

A replay of the call will be available for 48 hours following its conclusion and can be accessed by dialing (877) 344-7529 for domestic callers, (855) 669-9658 for Canadian callers or (412) 317-0088 for other international callers. Please use event passcode 10135501.