On November 5, 2020 ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported that it has completed the first closing of its previously announced private placement offering (the "Offering") of special warrants of the Company ("Special Warrants") at a price of $0.12 per Special Warrant, raising gross proceeds of $1,658,349.72 (Press release, ProMIS Neurosciences, NOV 5, 2020, View Source [SID1234570106]). A second closing (the "Final Closing") of the Offering is expected to be completed within a week.

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Each Special Warrant shall be exercisable, without payment of any additional consideration by the holder, into one common share of the Company and one transferable Common Share purchase warrant (a "Warrant"). Each Warrant will entitle the holder thereof to acquire one Common Share at an exercise price of $0.20 per Warrant Share for a period of 60 months until November 4, 2025, subject to acceleration of the expiry date as described below.

If at any time after the expiry of the four month hold period applicable to the Warrants, the twenty-day volume-weighted average trading price of the Shares on the TSX, or such other exchange on which the Shares may be listed, is greater than $0.60, the Company may deliver a notice to the holders of Warrants accelerating the expiry date to a date that is not less than 30 days following the date of such notice.

The net proceeds raised under the Offering will be used for general corporate purposes.

As soon as reasonably practicable after the Final Closing, the Company will take reasonable commercial steps to prepare and file with each of the securities regulatory authorities in each of the provinces of Canada, other than Quebec, in which the of Special Warrants are sold and obtain a receipt for, a final short form prospectus (the "Final Prospectus"), qualifying the distribution of the Shares and Warrants issuable upon exercise of the Special Warrants.

Each Special Warrant will be automatically exercised, without the payment of any additional consideration, into a Share and a Warrant on the date (the "Qualification Date") that is the earlier of (i) four (4) months and a day following Closing, and (ii) the 3rd business day after a receipt is issued for the Final Prospectus qualifying the distribution of the Shares and Warrants issuable upon the exercise of the Special Warrants. For greater certainty, except with the consent of the Company (such consent not to be unreasonably withheld), no Special Warrants may be exercised by the holder thereof prior to the Qualification Date.

In connection with the first tranche of the Offering, the Company has paid cash finder’s fees in the amount of $50,064 and issue a total of 417,200 compensation warrants (the "Compensation Warrants") equal to 7% of the number of Special Warrants issued under the Offering. The Compensation Warrants have the same terms as the Warrants.

The Offering is subject to receipt of the final approval of the TSX.

Five insiders of the Company participated in the Offering and subscribed for total of 1,097,915 Special Warrants. Such participation is considered to be a "related party transaction" as defined under Multilateral Instrument 61-101 ("MI 61-101"). The transaction is exempt from the formal valuation and minority shareholder approval requirements of MI 61-101, as neither the fair market value of any securities issued to nor the consideration paid by such persons exceeded 25% of the Company’s market capitalization.

This press release is not an offer to sell or the solicitation of an offer to buy the securities in the United States or in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to qualification or registration under the securities laws of such jurisdiction. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and such securities may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from U.S. registration requirements and applicable U.S. state securities laws.

On November 5, 2020 Bio-Techne Corporation (NASDAQ: TECH) reported that its Board of Directors has decided to pay a dividend of $0.32 per share for the quarter ended September 30, 2020 (Press release, Bio-Techne, NOV 5, 2020, View Source [SID1234570105]). The quarterly dividend will be payable November 27, 2020 to all common shareholders of record on November 16, 2020. Future cash dividends will be considered by the Board of Directors on a quarterly basis.

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Regeneron has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On November 5, 2020 Merck (NYSE: MRK), known as MSD outside the United States and Canada, and VelosBio Inc. reported that the companies have entered into a definitive agreement pursuant to which Merck, through a subsidiary, will acquire all outstanding shares of VelosBio for $2.75 billion in cash, subject to certain customary adjustments (Press release, Merck & Co, NOV 5, 2020, View Source [SID1234570089]). VelosBio is a privately held clinical-stage biopharmaceutical company committed to developing first-in-class cancer therapies targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1). VelosBio’s lead investigational candidate is VLS-101, an antibody-drug conjugate (ADC) targeting ROR1 that is currently being evaluated in a Phase 1 and a Phase 2 clinical trial for the treatment of patients with hematologic malignancies and solid tumors, respectively.

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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

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"At Merck, we continue to bolster our growing oncology pipeline with strategic acquisitions that both complement our current portfolio and strengthen our long-term growth potential," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. "Pioneering work by VelosBio scientists has yielded VLS-101, which in early studies has provided notable evidence of activity in heavily pretreated patients with refractory hematological malignancies, including mantel cell lymphoma and diffuse large B-cell lymphoma."

In October 2020, VelosBio announced the initiation of a Phase 2 clinical trial (NCT04504916) to evaluate VLS-101 for the treatment of patients with solid tumors, including patients with triple-negative breast cancer (TNBC), hormone receptor-positive and/or HER2-positive breast cancer, and non-squamous non-small-cell lung cancer (NSCLC). In early clinical trials, VLS-101 demonstrated a manageable safety profile and early signs of anti-tumor activity. Results of a Phase 1 clinical trial, to be presented virtually at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Dec. 5-8, 2020), showed that VLS-101 resulted in objective clinical responses, including complete responses, in 47% (n=7/15) of patients with mantle cell lymphoma (MCL) and 80% (n=4/5) of patients with diffuse large B-cell lymphoma. Patients in this Phase 1 trial had been heavily pretreated with other anticancer medications, and their cancers had failed to respond or had relapsed after initially responding to these other anticancer medications. In addition, VelosBio is developing a preclinical pipeline of next-generation ADCs and bispecific antibodies targeting ROR1 with the potential to complement VLS-101 by offering alternative methods of tumor cell killing.

"Merck is a recognized leader in oncology, and this acquisition reflects the hard work and commitment of all the employees at VelosBio in advancing the science of ROR1," said Dave Johnson, founder and chief executive officer at VelosBio. "We are very pleased that Merck has recognized the value of our first-in-class ROR1-directed investigational therapeutics. As part of Merck’s oncology pipeline, our lead product candidate, VLS-101, is now well positioned to achieve its maximum potential to benefit appropriate cancer patients in need."

The closing of the transaction, which is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions, is expected by the end of 2020.

Merck was represented by Gibson Dunn & Crutcher LLP as legal advisor and J.P. Morgan Securities LLC as financial advisor. VelosBio was represented by Cooley LLP as legal advisor and Centerview Partners LLC as financial advisor.

About VLS-101

VLS-101 is an investigational ADC comprising a monoclonal antibody targeting ROR1 that is linked to a chemotherapeutic agent called monomethyl auristatin E (MMAE). After the antibody binds to ROR1 on cancer cells, the ADC is designed to enter those cells and release MMAE to destroy the cancer cells. In mouse models of human hematologic malignancies and solid tumors, VLS-101 showed robust antitumor activity. VLS-101 is in clinical development for patients with previously treated hematologic malignancies and solid tumors. The U.S. Food and Drug Administration has granted VLS-101 orphan drug and fast track designations for the treatment of MCL.

Merck’s Focus on Cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

On November 5, 2020 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, reported financial results for the third quarter ended Sept. 30, 2020, and provided an update on programs and progress (Press release, Synlogic, NOV 5, 2020, View Source [SID1234570088]).

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"We are gaining momentum across our three clinical stage programs as we head into the end of the year," said Aoife Brennan, M.B. Ch.B., Synlogic’s President and Chief Executive Officer. "We are ahead of schedule in moving SYNB8802—our investigational Synthetic Biotic for the treatment of Enteric Hyperoxaluria—into the clinic and initiated the Phase 2 SynPheny-1 study in PKU patients. On the corporate side, we have strengthened our leadership team with the addition of Dr. David Hava as Chief Scientific Officer. With a strong cash runway, we have the resources to execute on our key clinical milestones over the next 12 months, extending our lead as the premier platform for engineered Synthetic Biotic medicines."

"We are thrilled with the recent progress moving two programs forward in the clinic. Initiation of the Phase 2 SynPheny-1 study of SYNB1618 puts us on track to see data in PKU patients around the middle of next year," said Richard Riese, M.D., Synlogic’s Chief Medical Officer. "The SynPheny-1 study will provide, for the first-time, data on the ability of SYNB1618 to lower blood Phe in a meaningful way for the 70% of PKU patients who are not served by existing oral therapies."

Dr. Riese further stated, "Our second metabolic program, SYNB8802 for Enteric Hyperoxaluria, has the potential to improve kidney health in an area of underappreciated need. Enteric Hyperoxaluria patients have no approved therapies to control dangerously high levels of urinary oxalate. We have initiated the Phase 1 trial and are looking forward to rapidly advancing SYNB8802 through clinical development."

2020 Priorities & Highlights

The Metabolic Portfolio:

Initiation of a Phase 2 clinical trial to evaluate SYNB1618 in patients with Phenylketonuria (PKU), with data expected in the middle of 2021. SYNB1618 is an orally administered Synthetic Biotic medicine being developed as a potential treatment for PKU.
Based on feedback from patients and caregivers Synlogic believes both current and emerging treatment options will continue to leave too many patients behind.
Synthetic Biotic medicines offer potential for a safe, tolerable, reversible and oral therapy, which controls Phe levels by consuming Phe in the GI tract.
Clinical sites have been activated across the United States and Synlogic expects to dose the first patient in the Phase 2 SynPheny-1 study of SYNB1618 by year-end.
SynPheny-1 is designed to evaluate plasma Phe lowering of a solid oral formulation of SYNB1618 in adult PKU patients who do not benefit from, or do not tolerate, existing therapies such as Kuvan or Palynziq.
In addition, the study is expected to provide valuable information to validate predictive pharmacodynamic and preclinical modeling.
Advancement of SYNB8802 for the treatment of Enteric Hyperoxaluria. Synlogic is developing SYNB8802 to treat Enteric Hyperoxaluria.
SYNB8802 has commenced a Phase 1 clinical study. The first healthy volunteer cohort was dosed in November 2020.
Synlogic presented a poster at the American Society of Nephrology’s (ASN) 2020 Kidney Week Virtual Event on SYNB8802, which demonstrated:
In both nonhuman primate and mouse models of acute Hyperoxaluria, SYNB8802 significantly reduced oxalate levels.
Proprietary in-silico simulations of predicted human exposure suggest SYNB8802 has the potential to achieve between 20% and 50% urinary oxalate lowering in patients at doses that have been well tolerated in prior trials of Synthetic Biotic medicines.
The Immunomodulation Portfolio:

Continuation of the monotherapy arm of the Phase 1 clinical study of SYNB1891 in patients with advanced solid tumors or lymphoma. SYNB1891 is currently in Phase 1 clinical development in patients with advanced solid tumors or lymphoma.
Enrollment in the Phase 1 trial continues per plan.
Synlogic expects to share an update on the initial dose cohorts of the monotherapy arm of the Phase 1 clinical study before the end of the year, per plan.
Initiation of the combination arm of the Phase 1 clinical study, with the anti-PD-1 antibody Tecentriq (atezolizumab), is expected in the first half of 2021.
Corporate Profile:

Synlogic strengthens Leadership Team. Synlogic appointed Dr. David Hava, Ph.D., as Chief Scientific Officer.
Dr. Hava brings over a decade of senior experience in research and development to Synlogic, including deep academic expertise in pillars of synthetic biology. Dr. Hava is an experienced drug hunter who has brought multiple programs from ideation into and through the clinic and has led numerous successful partnerships. Before joining Synlogic, Dr. Hava served as CSO at Metera Pharmaceuticals. He has also served as CSO at Pulmatrix Inc., where he led the Research and Development organization in the company’s development of their delivery platform. Dr. Hava earned his Ph.D. in Molecular Biology and Microbiology at Tufts University and he completed his postdoctoral training at Harvard Medical School studying immunology and host-pathogen interactions.
Third Quarter 2020 Financial Results
As of September 30, 2020, Synlogic had cash, cash equivalents and short-term investments of $102.0 million.

For the three months ended Sept. 30, 2020, Synlogic reported a consolidated net loss of $13.2 million or $0.36 per share, compared to a consolidated net loss of $13.3 million or $0.39 per share, for the corresponding period in 2019.

Research and development expenses were $10.5 million for the three months ended September 30, 2020 compared to $10.6 million for the corresponding period in 2019.

General and administrative expenses for the three months ended September 30, 2020 were $3.0 million compared to $3.9 million for the corresponding period in 2019.

There was no revenue for the three months ending September 30, 2020 and $0.3 million for the three months ending September 30, 2019. Revenue for the prior period was associated with Synlogic’s collaboration with AbbVie to develop Synthetic Biotic medicines for the treatment of irritable bowel disease, which was terminated in May 2020.

Financial Outlook
Based upon its current operating plan, Synlogic expects to have a projected cash runway into 2022.

Conference Call & Webcast Information
Synlogic will host a conference call and live webcast at 8:30 a.m. ET today, Thursday, Nov. 5, 2020. To access the live webcast, please visit the "Event Calendar" page within the Investors and Media section of the Synlogic website. Investors may listen to the call by dialing +1 (844) 815-2882 from locations in the United States or +1 (213) 660-0926 from outside the United States. The conference ID number is 8557525. A replay will be available for 30 days on the Investors and Media section of the Synlogic website.