On November 13, 2019 Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more patients, reported financial results for the third quarter ended September 30, 2019 and recent business highlights (Press release, Magenta Therapeutics, NOV 13, 2019, View Source [SID1234551122]).

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"Magenta has a big vision: to bring the curative power of immune reset through stem cell transplant to patients with autoimmune diseases, genetic diseases and blood cancers. At ASH (Free ASH Whitepaper) next month, we are looking forward to sharing important new data from across our portfolio. These will include clinical data from our MGTA-145 program, which we are developing as a new first-line standard of care for stem cell mobilization. We will also present the first gene therapy data on our CD117-ADC, which we are developing as a non-genotoxic preparation regimen for gene therapy and transplant," said Jason Gardner, D.Phil., Chief Executive Officer and President, Magenta Therapeutics. "In addition, earlier this week we presented our first data in autoimmune disease, showing that a single dose of our CD45-ADC led to successful immune reset in disease models of multiple sclerosis, systemic sclerosis and inflammatory arthritis. Immune reset through stem cell transplant has previously demonstrated durable remissions in thousands of patients with autoimmune diseases such as multiple sclerosis and systemic sclerosis, and it is recommended in multiple guidelines in US and Europe."

Recent Business Highlights:

First clinical data for MGTA-145 stem cell mobilization program and groundbreaking CD117-ADC gene therapy data to be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting: On November 6th, 2019, Magenta announced that the Company will share results from six abstracts at ASH (Free ASH Whitepaper) in December 2019, covering Magenta’s patient preparation, mobilization and cell therapy programs. The Company will present clinical data for the MGTA-145 stem cell mobilization program, building on the positive early data in the ASH (Free ASH Whitepaper) abstract. Magenta is developing MGTA-145 to be the new standard of care for first-line stem cell mobilization, with mobilization and collection taking place in a single day without the use of G-CSF, the current standard of care. The Company will also highlight important proof-of-concept data from the CD117-ADC patient preparation program. In a rhesus model of gene therapy, a single dose of CD117-ADC enabled engraftment of stem cells modified with the β-globin gene, the gene that causes sickle cell disease and β-thalassemia when mutated. These results showed for the first time that a single dose of CD117-ADC can enable successful gene therapy transplant in non-human primates without the need for chemotherapy or radiation.

First Magenta preclinical immune reset data presented at the American College of Rheumatology (ACR) annual meeting: On November 10th, 2019, Magenta presented the first data on the use of targeted antibody-drug conjugates (ADCs) to reset the immune system and halt progression of autoimmune disease. Results showed that a single dose of C45-ADC removed disease-causing cells, enabled successful reset and rebuild of the immune system and was well tolerated in models of multiple sclerosis, systemic sclerosis and inflammatory arthritis. Further, a single dose of CD45-ADC significantly delayed disease onset in a model of multiple sclerosis that has successfully provided preclinical proof of concept for many clinically validated standard of care therapies.

Exercised option with Heidelberg Pharma for ADCs using an amanitin payload and targeting CD45: On November 11th, 2019, Magenta announced that it had exercised its option with Heidelberg Pharma for exclusive worldwide development and marketing rights for ADCs using an amanitin payload and targeting CD45.

Received Regenerative Medicine Advanced Therapies (RMAT) Designation for MGTA-456 in inherited metabolic disorders: In September 2019, Magenta announced that the FDA granted RMAT designation for MGTA-456, a one-time cell therapy for the treatment of multiple inherited metabolic disorders, based on encouraging clinical data generated to date in the Company’s ongoing Phase II trial. RMAT designation is a dedicated program designed to expedite the development and approval processes for promising pipeline products, including cell therapies. Potential advantages of the RMAT designation include all of the benefits of the fast track and breakthrough therapy designation programs, including early interactions with the FDA that may be used to discuss potential surrogate or intermediate endpoints to support accelerated approval.

Appointed Senior Vice President, Head of Translational Sciences; Chief Scientific Officer to transition out of Company: In October 2019, Magenta announced that it had hired Jan Pinkas, Ph.D., as Senior Vice President, Head of Translational Sciences. Dr. Pinkas is a seasoned scientist with deep expertise in leading drug development programs, including ADCs. Prior to joining Magenta, he was Head of Translational Research & Development at ImmunoGen, Inc., where he led nonclinical and translational research and development-related activities for all programs in discovery through late-stage clinical development. The Company also announced that Mike Cooke, Ph.D., Chief Scientific Officer, will leave Magenta to pursue other opportunities.

Financial Results:

Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2019, were $160.6 million compared to $142.6 million on December 31, 2018. Magenta anticipates that its cash, cash equivalents and marketable securities will be sufficient to fund operations and capital expenditures into the second half of 2021.

Research and Development Expenses: Research and development expenses were $16.5 million in the third quarter of 2019, compared to $11.4 million in the third quarter of 2018. The increase was driven primarily by investments in clinical activities for MGTA-145, as well as manufacturing related to our patient preparation programs.

General and Administrative Expenses: General and administrative expenses were $6.1 million for the third quarter of 2019, compared to $5.3 million for the third quarter of 2018. The increase was primarily due to an increase in professional fees and facility costs associated with the growth of the Company.

Net Loss: Net loss was $ 21.0 million for the third quarter of 2019, compared to net loss of $16.0 million for the third quarter of 2018.

On November 13, 2019 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported financial results for the third quarter ended September 30, 2019 (Press release, Personalis, NOV 13, 2019, View Source [SID1234551139]).

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Third Quarter 2019 Highlights

Record revenues of $17.2 million in the third quarter of 2019, versus $11.7 million in the third quarter of 2018, an increase of 47%

Received a new $38.1 million task order from the VA’s Million Veteran Program, increasing our unfulfilled orders with the VA MVP to approximately $82.5 million

Announced important customer and partner relationships, including agreements with Invectys, the University of New Mexico and the New Mexico Cancer Care Alliance

"I’m very pleased that we again achieved record quarterly revenues and grew 47% over the third quarter of last year. In September, we received a new order from the VA’s Million Veteran Program, which increased our cumulative orders received to date from the VA MVP to approximately $145 million," said John West, Chief Executive Officer. "In addition, many of our biopharmaceutical and prospective customers are actively evaluating our new platform ImmunoID NeXT and feedback has been resoundingly positive. We continue to anticipate ramping revenue volume of the NeXT platform increasingly throughout 2020."

Third Quarter 2019 Financial Results

Revenues were $17.2 million in the three months ended September 30, 2019, up 47% from $11.7 million in the same period of the prior year. Third quarter revenue growth was driven by an increase in volume for testing and analytical services provided to the U.S. Department of Veterans Affairs Million Veteran Program (VA MVP). In the third quarter, the VA MVP accounted for $12.9 million, or 75%, of revenues and the remaining $4.3 million, or 25%, was from biopharma and all other customers.

Gross margin was 32.8% for the three months ended September 30, 2019, compared with 38.5% in the same period of the prior year.

Operating expenses were $11.4 million for the three months ended September 30, 2019, compared with $6.2 million in the same period of the prior year.

Net loss was $6.9 million for the three months ended September 30, 2019 and net loss per share was $0.22 based on a weighted-average basic and diluted share count of 31.1 million, compared with a net loss of $3.6 million and a net loss per share of $1.19 on a weighted-average basic and diluted share count of 3.1 million last year.

Cash, cash equivalents, and short-term investments were $127.3 million as of September 30, 2019.

2019 and 2020 Outlook

Personalis expects full year 2019 revenues to be in the range of $64.5 million to $65.0 million, and full year 2020 revenues to be in the range of $77.5 million to $83.5 million.

Webcast and Conference Call Information

Personalis will host a conference call to discuss the third quarter financial results after market close on Wednesday, November 13, 2019 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using conference ID: 8749318. The live webinar can be accessed at View Source

On November 13, 2019 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported it has begun preclinical testing of its drug candidate, WP1122, which it believes may present a new approach to treating highly glycolytic tumors like pancreatic cancer and glioblastoma (Press release, Moleculin, NOV 13, 2019, View Source [SID1234551156]).

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

"WP1122 represents an opportunity to attack the metabolism of cancer by exploiting the Warburg principle, which explains that some tumors are highly dependent on glycolysis, a specific metabolism of glucose, for growth and survival," commented Walter Klemp, Moleculin’s Chairman and CEO. "What this means in practice is that tumors are vulnerable by being highly dependent on glucose availability. Cancer cells often consume up to 18 times as much glucose as their healthy normal cells’ neighbors, suggesting that we may be able to starve tumors by supplying them with glucose decoys that would inhibit glucose-based energy production. However, until the creation of WP1122, glucose decoys like 2-deoxy-D-glucose (‘2-DG’) lacked the drug-like properties to be effective, primarily because of rapid metabolism and a very short circulation time in the body, which then limits desired organ and tumor uptake."

Dr. Don Picker, Chief Science Officer for Moleculin, added: "WP1122 is a prodrug of 2-DG that has been shown in animal models to significantly increase the half-life of 2-DG and allows for increased uptake to targeted organs and tumors like the brain tumors and pancreatic cancer. Recent discoveries now also suggest that such a glucose decoy could critically impact a process known as glycosylation and glycan formation and that this type of activity can directly impact the function of PD-L1, enabling increased immune system response to cancer cells. We have been working on the clinical formulation of WP1122 for some time, and we are eager to now be taking the next key steps to getting WP1122 into the clinic."

On November 13, 2019 Bicycle Therapeutics plc (NASDAQ: BCYC) a clinical-stage biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycles) technology, reported that the first patient has been dosed in the Phase I dose escalation of its Phase I/II study of BT5528, a Bicycle Toxin Conjugate (BTC) targeting tumor antigen EphA2, in patients with advanced solid tumors associated with EphA2 expression (Press release, Bicycle Therapeutics, NOV 13, 2019, View Source [SID1234551172]). BT5528 is a second-generation BTC, which uses a valine-citrulline cleavable linker and a cytotoxin MMAE payload.

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"The initiation of this trial is an important step for Bicycle as BT5528 is our first U.S. investigational new drug (IND), and this is the first clinical study to be sponsored by the Company," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "BT5528 is also the first of our second-generation BTCs to enter the clinic and has demonstrated promising anti-tumor activity and tolerability across a broad range of preclinical studies. Notably, unlike existing EphA2-targeting antibody drug conjugates, BT5528 did not show coagulopathy in preclinical studies, and the first clinical dose has been well tolerated. We are pleased to have achieved another milestone in progressing our pipeline based on our novel and differentiated Bicycle technology, which we believe could generate potential first-in-class treatment options for patients suffering from cancer and other serious diseases."

The Phase I/II multi-center, open-label trial will evaluate BT5528 administered once-weekly as a single agent and in combination with nivolumab. The Phase I portion is a dose escalation primarily designed to assess the safety and tolerability of BT5528 and to determine a recommended Phase II dose (RP2D). Following selection of an RP2D, a Phase II dose expansion portion will be initiated with the primary objective of evaluating the clinical activity of BT5528. The study will be conducted across sites in the U.S. and the UK.

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.