On August 2, 2019 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will be presenting at the following investor conference and invited investors to participate by webcast (Press release, Exact Sciences, AUG 2, 2019, View Source [SID1234538081]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Canaccord Genuity Annual Growth Conference, Boston
Fireside Chat on August 7, 2019, at 9:00 a.m. EDT

The webcast can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

On August 2, 2019 Exicure, Inc. (Nasdaq: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported the closing of its previously announced underwritten public offering of 31,625,000 shares of its common stock to the public at $2.00 per share, which included the exercise in full by the underwriters of their option to purchase 4,125,000 additional shares of common stock (Press release, Exicure, AUG 2, 2019, View Source [SID1234538101]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In connection with the offering, Exicure’s common stock began trading on the Nasdaq Capital Market under the symbol "XCUR" at the opening of trading on July 31, 2019. Exicure expects to appoint to its board of directors an individual designated by Abingworth LLP and an individual designated by another investor in connection with their participation in the offering.

Exicure received gross proceeds of $63.25 million from the sale of common stock in the offering, prior to deducting the underwriting discounts and commissions and estimated offering expenses payable by it. Exicure intends to use the net proceeds from the offering to advance AST-008 through a Phase 1b/2 clinical trial; to develop an SNA therapeutic candidate for a neurology condition and advance it into Phase 1 clinical trials; and for general corporate purposes.

Guggenheim Securities acted as sole book-running manager for the offering. Chardan acted as lead manager for the offering. H.C. Wainwright & Co. and Ladenburg Thalmann acted as co-managers for the offering.

The securities described above were offered by Exicure pursuant to a shelf registration statement on Form S-3 (No. 333-230175) that was declared effective by the Securities and Exchange Commission (SEC) on July 24, 2019. A final prospectus supplement and accompanying prospectus describing the terms of the offering was filed with the SEC on August 1, 2019 and is available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained from: Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-5548, or by email at [email protected].

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

On August 2, 2019 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported financial results for the quarter ended June 30, 2019 (Press release, ImmunoGen, AUG 2, 2019, View Source [SID1234538082]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In the second quarter, we took important steps towards finalizing the design of the registration study for mirvetuximab soravtansine in folate receptor alpha (FRα)-high platinum-resistant ovarian cancer, prioritizing our portfolio of earlier-stage product candidates, and extending our cash runway with the completion of our operational review," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "Over the back half of 2019, we plan to meet with regulators regarding the final design of the registration study for mirvetuximab with the goal of initiating enrollment by end of year. Additionally, we look forward to presenting the full FORWARD I data and initial FORWARD II triplet data evaluating mirvetuximab in combination with carboplatin and Avastin (bevacizumab) at ESMO (Free ESMO Whitepaper)."

Enyedy continued, "In parallel, we have determined a recommended Phase 2 dose and schedule for IMGN632 and filed a protocol to support combination studies, as well as evaluate single-agent safety and efficacy in acute myeloid leukemia (AML) patients with minimal residual disease (MRD+) following frontline induction therapy. With the benefit of approximately $240 million on the balance sheet and the completion of our operational review, we are in a strong financial position to execute across our prioritized portfolio."

RECENT PROGRESS

Presented mature data demonstrating significant anti-tumor activity, as well as favorable safety and tolerability, from the FORWARD II expansion cohort evaluating mirvetuximab in combination with bevacizumab in patients with FRα-positive platinum-resistant ovarian cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June.
Accelerated enrollment in the FORWARD II mirvetuximab plus bevacizumab combination cohort in ovarian cancer patients for whom a non-platinum-based regimen would be an appropriate next therapy.
Determined the recommended Phase 2 dose and schedule for IMGN632 and filed the protocol to initiate combination studies with Vidaza (azacitidine) and Venclexta (venetoclax) in relapsed/refractory AML patients and to evaluate IMGN632 in MRD+ patients following frontline induction therapy.
Continued enrollment in the Phase 1 expansion study of IMGN632 in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Advanced IND-enabling activities for IMGC936, a novel ADAM9-targeting ADC in co-development with MacroGenics.
Completed operational review expected to extend the Company’s cash runway through the readout of the mirvetuximab pivotal study in platinum-resistant ovarian cancer.
ANTICIPATED UPCOMING EVENTS

Meet with the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) in the second half of this year to review the design of the next Phase 3 study of mirvetuximab soravtansine.
Complete enrollment in the FORWARD II mirvetuximab plus bevacizumab combination cohort in the third quarter.
Present full FORWARD I data (oral presentation) and initial FORWARD II triplet data (poster presentation) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in late September.
Initiate the Phase 3 registration study of mirvetuximab as a monotherapy for women with FRα-high, platinum-resistant ovarian cancer by the end of this year.
Commence enrollment in the IMGN632 combination and single-agent MRD+ Phase 2 cohorts.
Present preclinical combination and updated monotherapy data for IMGN632 at the American Society of Hematology (ASH) (Free ASH Whitepaper) Congress.
FINANCIAL RESULTS

Revenues for the quarter ended June 30, 2019 were $15.5 million, compared with $9.3 million for the quarter ended June 30, 2018. Revenues in the second quarter of 2019 included $10.4 million in non-cash royalty revenues, compared with $7.2 million for the second quarter of 2018. License and milestone fees of $5.1 million for the second quarter of 2019 included recognition and receipt of a $5 million milestone pursuant to a license agreement with Genentech, a member of the Roche Group, compared to $1.3 million of upfront license fees recognized in the second quarter of 2018. Revenues for the prior year period also included $0.4 million of research and development (R&D) support fees and $0.3 million of clinical materials revenue, compared with $0.1 million of similar fees earned in the current period.

Operating expenses for the second quarter of 2019 were $56.6 million, compared with $48.0 million for the same quarter in 2018. The increase was driven by a $19.3 million restructuring charge recorded in the current period resulting from the operational changes announced on June 27, 2019, which includes a one-time severance charge, retention costs, and losses recorded on laboratory equipment, compared to a $0.7 million charge recorded in the second quarter of 2018 related to the decommissioning of the Company’s Norwood facility. R&D expenses were $28.6 million in the second quarter of 2019, compared with $38.7 million for the second quarter of 2018. This decrease was primarily due to lower personnel expenses driven by adjustments made in the current quarter to bonus and stock compensation expense as a result of the restructuring of the business, lower clinical trial costs in the current period driven by patient enrollment in the FORWARD I Phase 3 clinical trial during the prior year period, and lower external manufacturing costs. General and administrative expenses were flat at $8.7 million in the second quarter of both 2019 and 2018.

ImmunoGen reported a net loss of $43.4 million, or $0.29 per basic and diluted share, for the second quarter of 2019, compared with a net loss of $41.6 million, or $0.31 per basic and diluted share, for the same quarter last year. Weighted average shares outstanding increased to 148.1 million from 134.4 million in those quarters.

ImmunoGen had $239.8 million in cash and cash equivalents as of June 30, 2019, compared with $262.3 million as of December 31, 2018, and had $2.1 million of convertible debt outstanding in each period. Cash used in operations was $20.8 million for the first six months of 2019, compared with cash used in operations of $85.3 million for the same period in 2018. The current period benefited from $65.2 million of net proceeds generated from the sale of the Company’s residual rights to Kadcyla (ado-trastuzumab emtasine) royalties in January 2019. Capital expenditures were $2.4 million and $2.1 million for the first six months of 2019 and 2018, respectively.

FINANCIAL GUIDANCE

Following the completion of its operational review in June 2019, ImmunoGen has updated its financial guidance for 2019 as follows:

revenues between $40 million and $45 million;
operating expenses between $175 million and $180 million; and
cash and cash equivalents at December 31, 2019, between $165 million and $170 million.
ImmunoGen expects that its current cash, together with expense reductions resulting from the operational changes previously announced and anticipated cash receipts from partners, will fund operations through the release of top-line results from the upcoming mirvetuximab Phase 3 study in platinum-resistant ovarian cancer, which are expected in the first half of 2022.

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, dial +1-323-794-2093; the conference ID is 9100112. The call may also be accessed through the Investors and Media section of the Company’s website at www.immunogen.com.

On August 2, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported financial results for the second quarter ended June 30, 2019 (Press release, Zymeworks, AUG 2, 2019, View Source [SID1234538102]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We had a notable second quarter that included significant activity from our pharmaceutical partners and was highlighted by a successful financing," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "We are well capitalized to accelerate and expand the clinical development of both ZW25 and ZW49 and plan to provide updates in the near-term beginning with ZW25 single agent and chemo combination data this fall."

Second Quarter 2019 Business Highlights and Recent Developments

Raised Over $200 Million in Upsized Public Offering
Zymeworks completed a public offering of 7,013,892 common shares (including the exercise in full of the underwriters’ over-allotment to purchase 1,458,336 additional common shares) and, in lieu of common shares, to a certain investor, pre-funded warrants to purchase up to 4,166,690 common shares, for aggregate gross proceeds of US$201.3 million.
First ZymeLink Platform Deal and Progress from Existing Partners
We granted Iconic Therapeutics a license to the ZymeLink Antibody Drug Conjugate (ADC) platform for its ICON-2 Tissue Factor ADC, marking our first collaboration leveraging the ZymeLink platform and our third technology platform licensed to a collaborator. In addition, we received milestone payments from Daiichi Sankyo, Merck, and Celgene as a result of advancements they made with their Azymetric bispecifics towards the clinic. Furthermore, GSK broadened its Azymetric platform license resulting in increased potential milestone payments and royalties to Zymeworks.

Received Fast Track Designation to Expedite ZW25’s Development
The FDA granted ZW25 Fast Track designation for frontline treatment of patients with advanced HER2-overexpressing gastroesophageal adenocarcinoma, an area of significant unmet medical need. Zymeworks is currently enrolling patients in a frontline Phase 2 clinical trial in combination with standard of care chemotherapy with plans to initiate a registrational trial in 2020.

Expanded Board of Directors Increases Commercial Expertise
As Zymeworks advances into late-stage clinical development, we added Dr. Sue Mahony and Troy Cox to our Board, two pharmaceutical executives with extensive global strategic development and therapeutic commercialization experience.

Financial Results for the Quarter Ended June 30, 2019

Revenue for the three months ended June 30, 2019 was $7.9 million as compared to $22.0 million in the same period of 2018. Revenue for the second quarter of 2019 includes a $2.0 million development milestone received from Merck on its completion of a GLP toxicology study for its first program, $3.5 million received upon Daiichi Sankyo’s exercise of a commercial license option, $1.0 million recognized in relation to milestone revenue from Iconic, as well as a total of $1.4 million in research support payments. Revenue in the same period in 2018 was due to an $18.0 million upfront technology access fee in relation to our second licensing agreement with Daiichi Sankyo and a $4.0 million collaboration expansion fee from Celgene.

For the three months ended June 30, 2019, research and development expenses were $23.8 million as compared to $15.4 million in the same period of the prior year. The change was primarily due to an increase in clinical trial activity and associated drug manufacturing for ZW25, as well as an increase in other research and discovery activities compared to the same period in 2018. Research and development expenses included non-cash stock-based compensation expense of $1.5 million from equity-classified stock options and $1.6 million expense related to the non-cash mark-to-market revaluation of certain historical liability-classified stock options.

For the three months ended June 30, 2019, general and administrative expenses were $12.8 million as compared to $8.6 million in the same period in 2018, primarily due to an increase in employee compensation expense due to increased head count in 2019 over 2018, including non-cash stock-based compensation. General and administrative expenses in 2019 included non-cash stock-based compensation expense of $1.6 million from equity-classified stock options and $4.8 million related to the non-cash mark-to-market revaluation of certain historical liability-classified stock options.

The net loss for the three months ended June 30, 2019, was $29.1 million as compared to $5.9 million in the same period of 2018. This was primarily due to a decrease in revenue and an increase in research and development expenses associated with our lead therapeutic candidates and other programs, as well as increase in general and administrative expenses and the impairment expense recognized on our acquired IPR&D in 2019. This increase was partially offset by warrant valuation expenses recognized in 2018.

Zymeworks expects research and development expenditures to increase over time in line with the advancement and expansion of clinical development of our product candidates, as well as our ongoing preclinical research activities. Additionally, Zymeworks anticipates continuing to receive revenue from our existing and future strategic partnerships, including technology access fees, milestone-based payments and research support payments. However, Zymeworks’ ability to receive these payments is dependent upon either Zymeworks or our collaborators successfully completing specified research and development activities.

As of June 30, 2019, Zymeworks had $355.7 million in cash and cash equivalents and short-term investments.

On August 2, 2019 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it will release its second quarter 2019 financial results and operational highlights before open of U.S. markets on Thursday, August 8, 2019 (Press release, Autolus, AUG 2, 2019, View Source [SID1234550815]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Management will host a conference call at 8:30 a.m. ET/1:30 p.m. BST the same day to discuss the company’s financial results and provide a general business update. To listen to the webcast and view the accompanying slide presentation, please go to: View Source

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 2763978 . After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 2763978.