On October 8, 2019 Sutro Biopharma, Inc. (NASDAQ: STRO) reported that it has achieved a milestone under its collaboration and license agreement with the healthcare division of Merck KGaA, Darmstadt, Germany and is entitled to receive a milestone payment (Press release, Sutro Biopharma, OCT 8, 2019, View Source [SID1234540101]). The milestone was achieved upon the designation by Merck KGaA, Darmstadt, Germany of an undisclosed bispecific antibody drug conjugate (ADC) as a clinical development candidate with approval to advance to IND-enabling studies. This candidate was discovered using Sutro’s XpressCF+ drug discovery and manufacturing technology and includes a proprietary linker-warhead also discovered by Sutro. The ADC is based on Merck´s strand-exchange engineered domain (SEED) platform to generate bispecific antibody-like molecules. As part of the agreement, Sutro will manufacture the ADC immediately for the early clinical supply of the candidate and is eligible for further milestones and royalties. Merck KGaA, Darmstadt, Germany will be responsible for drug product, clinical development and commercialization of this clinical development candidate.

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!

"The achievement of this milestone marks our fourth ADC clinical product candidate in three years, further validating our XpressCF+ drug discovery and manufacturing technology which enables iterative optimization through cell-free protein synthesis and site specific conjugation as well as our linker-warhead, all of which are designed to achieve an improved therapeutic window," said Bill Newell, Sutro’s Chief Executive Officer. "We look forward to continuing our collaboration with Merck KGaA, Darmstadt, Germany as we seek to discover the next-generation of oncology therapeutics and transform the lives of cancer patients in urgent need of new therapies."

"We are extremely excited to reach this milestone; the development of a therapeutic candidate that incorporates site-specific homogeneous drug conjugation onto a bispecific antibody for the treatment of solid tumors is another demonstration of the versatility of our technology platform," said Trevor Hallam, PhD, Sutro’s Chief Scientific Officer.

Under the terms of the agreement announced in 2014, Sutro and Merck KGaA, Darmstadt, Germany have collaborated to discover and develop ADCs utilizing Sutro’s cell-free protein synthesis platform, Xpress CF+. Merck KGaA, Darmstadt, Germany will be responsible for drug product, clinical development and commercialization of any resulting products. Sutro is eligible to receive certain pre-commercial milestone payments and tiered royalties ranging from low-to-mid single digit percentages, along with certain additional one-time royalties, on worldwide sales of any commercial products. Further financial details are not being disclosed.

On October 8, 2019 Bristol-Myers Squibb Company (NYSE:BMY) ("Bristol-Myers Squibb") reported the extension of the expiration date of the offers to exchange (the "Exchange Offers") notes (the "Celgene Notes") issued by Celgene Corporation (NASDAQ:CELG) ("Celgene") for up to $19,850,000,000 aggregate principal amount of new notes to be issued by Bristol-Myers Squibb Company (the "Bristol-Myers Squibb Notes") and cash and the related consent solicitations (the "Consent Solicitations") being made by Bristol-Myers Squibb on behalf of Celgene to adopt certain proposed amendments (the "Amendments") to the indentures governing the Celgene Notes (Press release, Bristol-Myers Squibb, OCT 8, 2019, View Source;1 [SID1234540100]). Bristol-Myers Squibb hereby extends such expiration date from 5:00 p.m., New York City time, on October 15, 2019, to 5:00 p.m., New York City time, on October 25, 2019 (as the same may be further extended, the "Expiration Date").

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!

On the early participation date of May 1, 2019, requisite consents were received and supplemental indentures were executed, eliminating substantially all restrictive covenants and certain events of default and other provisions in each of the indentures governing the Celgene Notes. Such supplemental indentures will only become operative upon the settlement date of the Exchange Offers.

The Exchange Offers and Consent Solicitations are being made pursuant to the terms and subject to the conditions set forth in the confidential offering memorandum and consent solicitation statement dated April 17, 2019 and the related letter of transmittal hereby, each as amended by the press releases dated May 1, 2019, May 24, 2019, June 28, 2019, September 23, 2019 and as amended hereby, and are conditioned upon the closing of Bristol-Myers Squibb’s acquisition of Celgene (the "Merger"), which condition may not be waived by Bristol-Myers Squibb, and certain other conditions that may be waived by Bristol-Myers Squibb.

The settlement date for the Exchange Offers is expected to occur promptly after the Expiration Date and on or about the closing date of the Merger. The closing of the Merger is expected to occur by the end of 2019. As a result, the Expiration Date may be further extended one or more times. Bristol-Myers Squibb will provide notice of any such extension in advance of the Expiration Date.

Except as described in this press release, all other terms of the Exchange Offers and Consent Solicitations remain unchanged.

As of 5:00 p.m., New York City time, on October 7, 2019, the principal amounts of Celgene Notes set forth in the table below had been validly tendered and not validly withdrawn:

Documents relating to the Exchange Offers and Consent Solicitations will only be distributed to eligible holders of Celgene Notes who complete and return an eligibility form confirming that they are either a "qualified institutional buyer" under Rule 144A or not a "U.S. person" and outside the United States under Regulation S for purposes of applicable securities laws. Except as amended by the press releases dated May 1, 2019, May 24, 2019, June 28, 2019, September 23, 2019 and as amended hereby, the complete terms and conditions of the Exchange Offers and Consent Solicitations are described in the confidential offering memorandum and consent solicitation statement dated April 17, 2019 and the related letter of transmittal, copies of which may be obtained by contacting Global Bondholder Services Corporation, the exchange agent and information agent in connection with the Exchange Offers and Consent Solicitations, at (866) 470 3900 (U.S. toll-free) or (212) 430 3774 (banks and brokers). The eligibility form is available electronically at: View Source

This press release does not constitute an offer to sell or purchase, or a solicitation of an offer to sell or purchase, or the solicitation of tenders or consents with respect to, any security. No offer, solicitation, purchase or sale will be made in any jurisdiction in which such an offer, solicitation or sale would be unlawful. The Exchange Offers and Consent Solicitations are being made solely pursuant to the confidential offering memorandum and consent solicitation statement dated April 17, 2019, as amended by the press releases dated May 1, 2019, May 24, 2019, June 28, 2019, September 23, 2019 and as amended hereby, and the related letter of transmittal and only to such persons and in such jurisdictions as are permitted under applicable law.

The Bristol-Myers Squibb Notes offered in the Exchange Offers have not been registered under the Securities Act of 1933, as amended, or any state securities laws. Therefore, the Bristol-Myers Squibb Notes may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act of 1933, as amended, and any applicable state securities laws.

On October 8, 2019 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company plans to release its third-quarter 2019 financial results after the close of the U.S. financial markets on Oct. 29, 2019 (Press release, Exact Sciences, OCT 8, 2019, View Source [SID1234540099]). Following the release, company management will host a webcast and conference call at 5 p.m. ET to discuss financial results and business progress.

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!

Exact Sciences Corporation Logo (PRNewsfoto/EXACT SCIENCES CORP)
Third-Quarter 2019 Webcast & Conference Call Details

Date:

Tuesday, Oct. 29, 2019

Time:

5 p.m. ET, 4 p.m. CT

Webcast:

The live webcast can be accessed at www.exactsciences.com

Telephone:

Domestic callers, dial 833-235-7650
International callers, dial +1 647-689-4171
Access code for both domestic and international callers: 4168628

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 4168628. The webcast, conference call and replay are open to all interested parties.

On October 7, 2019 Nordic Nanovector ASA (OSE: NANO) reported that it has signed a long-term global supply agreement with a subsidiary of ITM Isotopen Technologien München AG (ITM), Isotope Technologies Garching GmbH (ITG) to ensure the supply of high quality, no-carrier-added (n.c.a.) Lutetium-177, a key component of Betalutin (177Lu-lilotomab-satetraxetan) for R&D, clinical and commercial uses (Press release, Nordic Nanovector, OCT 7, 2019, View Source [SID1234553444]).

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!

ITM, a biotechnology and radiopharmaceutical group of companies and world-leader in the development and production of radiopharmaceuticals and radionuclides for the targeted treatment of cancers as well as for diagnostics, has been supplying n.c.a. Lutetium-177 (EndolucinBeta)* to Nordic Nanovector since 2010.

Marco Renoldi, Chief Operating Officer at Nordic Nanovector, said: "We are pleased to extend our collaboration with a long-time and reliable partner such as ITM. This global supply agreement is a key milestone in the implementation of our CMC (Chemistry, Manufacturing and Controls) strategy for gaining regulatory approval for Betalutin and its subsequent commercial rollout, as it provides certainty of continued supply of n.c.a. Lutetium-177 during clinical development as well as after launch. The agreement with ITM, alongside other manufacturing supply and development agreements in place with specialist manufacturers at all stages of the manufacturing and supply chain for Betalutin strengthens our confidence in the ability to deliver a reliable and sustainable supply chain in support of the launch of our lead asset."

Steffen Schuster, CEO of ITM, added: "Nordic Nanovector is one of our longstanding partners and we are delighted that Nordic Nanovector has reaffirmed their confidence through this long-term supply agreement for EndolucinBeta. In addition to the development of our own pipeline, we have once again been able to gain a strategic partner for the development of targeted radiopharmaceuticals in Precision Oncology, thereby making a significant contribution to advancing a promising treatment option for difficult-to-treat cancers. With our manufacturing facilities around the world and our unrivaled logistics network, we feel well equipped to reliably meet our partners’ needs and to enter into further strategic relationships."

*EndolucinBeta, registered trademark of ITM’s EMA approved pharmaceutical n.c.a. Lutetium-177.

On November 7, 2019 BridgeBio Pharma, Inc. (NASDAQ: BBIO) reported financial results for the third quarter, which ended September 30, 2019, and provided recent highlights across the company’s research and development portfolio (Press release, BridgeBio, NOV 7, 2019, View Source [SID1234552609]).

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 continue to make progress towards achieving our goals, which ultimately is the delivery of meaningful medicines to patients with genetic diseases," said Neil Kumar, Ph.D., founder and chief executive officer of BridgeBio. "We will present new data from our TTR stabilizer program this month at the American Heart Association (AHA). We are also on track to begin filing this year our rolling new drug application for BBP-870, a treatment for the often-fatal genetic disease molybdenum cofactor deficiency type A. We are growing our pipeline as well, adding BBP-418, a novel treatment for the neuromuscular disorder limb-girdle muscular dystrophy type 2i. We remain on track to put five or more programs into the clinic next year on a risk-adjusted basis."

Recent Highlights:

BBP-831 – FGFR1-3 inhibitor for achondroplasia: Initiated PROPEL, a prospective observational study in children with achondroplasia, the most common genetic form of short stature (NCT04035811). The study will establish annualized growth velocity (AGV) for each child over a minimum period of six months. PROPEL is designed to provide baseline measurements for children who enroll in PROPEL2, a Phase 2 study of low-dose infigratinib in achondroplasia which is on track to start in 2020. Additionally, in October 2019, new preclinical data supporting tolerability and efficacy of infigratinib in the mouse model of achondroplasia were reported at the American Society of Human Genetics conference (link to poster).

BBP-870 – cPMP replacement therapy for MoCD type A: Presented natural history study data at the Society of Inborn Errors of Metabolism Conference (link to poster) in September. These data suggest an urgent need for new therapies in molybdenum cofactor deficiency (MoCD) type A, an often-fatal rare genetic disease, and will be a critical component of the planned new drug application.

BBP-812 – Gene therapy candidate for Canavan disease: Opened a natural history study in Canavan disease (treatcanavan.com). Presented preclinical data (link to poster) demonstrating intravenous (IV) dosing of BridgeBio’s experimental therapy for Canavan disease (BBP-812) achieved broad central nervous system delivery; the IV approach is much less invasive compared to intrathecal or intracerebroventricular alternatives.

BBP-631 Gene therapy candidate for CAH: Presented preclinical update (link to poster) for gene therapy candidate BBP-631 in congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency wherein IV dosing of non-human primates with BBP-631 resulted in durable delivery and expression of the gene product to the adrenal tissue.

BBP-398 – SHP2 inhibitor for treatment-resistant cancer: Presented data (link to poster) highlighting the discovery and preclinical efficacy of BBP-398, a potent and selective SHP2 inhibitor, which is currently being prepared for the submission of an IND in 2020 for evaluation in RTK-driven cancer.

BBP-265 (AG10) – TTR stabilizer for ATTR: Granted Alexion Pharmaceuticals, Inc. an exclusive license to develop and commercialize AG10 in Japan for an upfront payment of $25 million and an equity investment of $25 million.

Pipeline growth: Announced addition of a new asset, BBP-418, to the pipeline. BBP-418 is a substrate supplementation therapy for the treatment of limb-girdle muscular dystrophy type 2i and is in IND-enabling studies. This condition affects an estimated 7,000 patients in the United States and European Union with no currently approved therapies.

Organizational growth: Added two new members to the senior leadership team. Brian Stolz joined as Chief Operating Officer of BridgeBio. Mr. Stolz most recently held the position of Chief People Officer at Activision Blizzard. Yi Ching Yau joined as Chief Accounting Officer of BridgeBio. Prior to joining BridgeBio, Ms. Yau served as the VP of Finance at Nektar Therapeutics.

Upcoming Milestones:

BBP-265 (AG10) – TTR stabilizer for ATTR: Plan to present interim analysis of the ongoing Phase 2 open label extension study (NCT03536767) of AG10 in patients with TTR amyloid cardiomyopathy, an inherited form of heart failure, at the American Heart Association 2019 Scientific Sessions in a Late-Breaking Featured Science Oral Presentation. A Phase 3 study of AG10 in ATTR-PN (ATTRibute-PN) is on track to begin in the first quarter of 2020.

BBP-870 – cPMP replacement therapy for MoCD type A: On track to initiate a rolling new drug application submission for our first-in-class therapy for molybdenum cofactor deficiency (MoCD) type A, BBP-870, by the end of 2019.

BBP-589 – COL7A protein replacement therapy for recessive dystrophic epidermolysis bullosa: Plan to share topline data from the ongoing Phase 1/2 study (NCT03752905) during 2020.

BBP-831 (infigratinib) – FGFR1-3 inhibitor for FGFR2+ cholangiocarcinoma: Plan to complete enrollment of the ongoing pivotal Phase 2 study (NCT02150967) in second line cholangiocarcinoma (bile duct cancer) and present updated results at a major oncology meeting in 2020. Remain on track to submit new drug application for FDA approval in 2020.

Consolidated cash, cash equivalents and marketable securities, excluding restricted cash, totaled $611.9 million as of September 30, 2019. Excluding Eidos, BridgeBio’s cash balance as of September 30, 2019 was $446.1 million compared to $162.4 million as of June 30, 2019. The net change in cash balance of $283.7 million reflects net proceeds received from BridgeBio’s initial public offering of $368.7 million, offset by the repurchase of a non-controlling interest for $26.4 million and approximately $58.6 million primarily for operating expenses.

Operating Expenses

Operating expenses for the three months that ended September 30, 2019 were $81.3 million, as compared to $41.5 million for the same period in the prior year. The increase in operating expenses of approximately $39.8 million was mainly attributable to increased research and development expenses related to the progression of our programs