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Arvinas, Inc. Announces Exercise of Underwriters’ Option to Purchase Additional Shares

On December 28, 2020 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation using its PROTAC Discovery Engine, reported that the underwriters of its previously announced underwritten public offering of common stock, which closed on December 18, 2020, have exercised in full their option to purchase additional shares of common stock at the public offering price, less underwriting discounts and commissions (Press release, Arvinas, DEC 28, 2020, View Source [SID1234573280]). After giving effect to the sale of 857,142 additional shares of common stock in the option closing, the total number of shares of common stock sold by Arvinas in the offering increased to 6,571,428 shares, which resulted in aggregate net proceeds of approximately $431.9 million. All of the shares were offered by Arvinas.

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Goldman Sachs & Co. LLC and Piper Sandler & Co. acted as joint book-running managers for the offering. Cantor Fitzgerald & Co. and BMO Capital Markets acted as co-managers for the offering.

An automatically effective shelf registration statement relating to the shares of common stock offered in the public offering was previously filed with the Securities and Exchange Commission. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 866-471-2526, facsimile: 212-906-9316 or by emailing [email protected]; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at 800-747-3924 or by email at [email protected].

This press release does not constitute an offer to sell, or a 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 any such state or jurisdiction.

Aprea Therapeutics Announces Results of Primary Endpoint from Phase 3 Trial of Eprenetapopt in TP53 Mutant Myelodysplastic Syndromes (MDS)

On December 28, 2020 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein, p53, reported results of the primary data cut from its Phase 3 clinical trial evaluating the safety and efficacy of eprenetapopt with azacitidine (AZA) versus AZA alone in TP53 mutant myelodysplastic syndromes (MDS) (Press release, Aprea, DEC 28, 2020, View Source [SID1234573279]). The trial did not meet the predefined primary endpoint of complete remission (CR) rate. Analysis of the primary endpoint at this data cut demonstrated a higher CR rate in the experimental arm receiving eprenetapopt with AZA versus the control arm receiving AZA alone, but did not reach statistical significance. In the intention-to-treat population of 154 patients, the CR rate in the eprenetapopt with AZA arm was 33.3% (95% CI: 23.1% – 44.9%) compared to 22.4% (95% CI: 13.6% – 33.4%) in the AZA alone arm (P = 0.13).

While analysis of certain secondary endpoints (ORR and duration of responses) appears to favor the experimental arm at this data cut, they are not significantly different. The median duration of overall survival at the primary data cut was similar between the arms. Additional patients in the study who have not achieved a CR remain on study treatment and the data will be analyzed at future pre-specified timepoints as set forth in the statistical analysis plan. The combination of eprenetapopt with AZA appeared well-tolerated, with an adverse event profile that was similar to the Company’s prior Phase 2 clinical trials. Subsequent analyses of the trial data, including secondary endpoints, will be conducted as the duration of patient follow-up increases. The Company expects to present the data at a future scientific conference.

"Though we are disappointed the topline results did not reach statistical significance, we continue to believe that eprenetapopt can offer clinical benefit to patients with TP53 mutant malignancies," said Dr. Eyal Attar, Chief Medical Officer of Aprea. "We will continue to analyze data as it matures and follow patients who are still receiving study treatment. Our other clinical trials continue to progress and we remain committed to pursuing our clinical development programs."

About the Phase 3 Trial in TP53 Mutant MDS

The Phase 3 trial enrolled 154 TP53 mutant MDS patients, randomized 1:1 to either the eprenetapopt with AZA arm or the AZA alone arm. Response criteria are those defined by International Working Group 2006 (IWG 2006) and include measures of peripheral blood counts and bone marrow blasts.

Zai Lab and Cullinan Oncology Announce Strategic Collaboration and License Agreement for CLN-081 in Greater China

On December 28, 2020 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, and Cullinan Oncology, a biopharmaceutical company focused on developing a diversified pipeline of targeted oncology and immuno-oncology therapies with transformative potential for cancer patients, reported an exclusive license agreement for the development, manufacturing and commercialization of CLN-081 in Greater China (Press release, Zai Laboratory, DEC 28, 2020, View Source [SID1234573278]).

Under the terms of the agreement, Cullinan Pearl, a Cullinan Oncology company, will receive a $20 million upfront payment, with the potential to receive up to an additional $211 million in development, regulatory and sales-based milestone payments. Cullinan Pearl is also eligible to receive high-single-digit to low-teen tiered royalties based on annual net sales of CLN-081 in Greater China, which includes mainland China, Hong Kong, Macau and Taiwan. Zai Lab obtains the exclusive right to develop, manufacture and commercialize CLN-081 in Greater China.

"Partnering with Cullinan for their potential best-in-class EGFR inhibitor targeting exon 20 insertion (Ex20ins) mutations provides potential synergies with Zai’s existing lung cancer franchise and further strengthens our disease area stronghold in lung cancer," said Dr. Samantha Du, Founder, Chairwoman and Chief Executive Officer of Zai Lab. "The unmet need in non-small-cell lung cancer with Ex20ins mutations is significant in China, where EGFR mutation rates are some of the highest in the world. Zai looks forward to working closely with Cullinan to address this large unmet medical need."

"Zai Lab is the ideal partner for innovative drug development and commercialization in Greater China, and we are excited to be collaborating with them on CLN-081," said Owen Hughes, Chief Executive Officer of Cullinan Oncology. "Approved EGFR inhibitors do not adequately address exon 20 insertion mutations. We believe that CLN-081, with its encouraging preliminary efficacy and safety data, can address a significant unmet medical need among lung cancer patients with these mutations. We look forward to working with Zai to initiate development of CLN-081 in China as soon as possible."

About CLN-081

CLN-081 is an orally available, small-molecule, next-generation, irreversible EGFR inhibitor designed to selectively target cells expressing mutant EGFR variants. CLN-081 is currently in a Phase 1/2a dose escalation and expansion trial evaluating oral, twice-daily administration of various doses in patients with NSCLC harboring EGFR Ex20ins mutations who have had at least one prior treatment with platinum-based chemotherapy or another approved standard therapy.

Anavex Life Sciences Reports Fiscal 2020 Year End Financial Results And Clinical Program Updates

On December 28, 2020 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, reported financial results for its fiscal year ended September 30, 2020 (Press release, Anavex Life Sciences, DEC 28, 2020, View Source [SID1234573277]).

Christopher U Missling, PhD, President and Chief Executive Officer of Anavex said: "Despite all of the new challenges, 2020 was an extraordinary year for Anavex, with significant progress across our portfolio, including our first positive, placebo-controlled, U.S. ANAVEX2-73 (blarcamesine) Rett syndrome trial, a positive Parkinson’s disease dementia trial, and further progress in Alzheimer’s disease. I want to thank the patients, doctors, and the Anavex team who made all of this progress possible. We look forward to building on this momentum with key milestones expected from multiple programs, including data on the ongoing late-stage Rett syndrome trials AVATAR and EXCELLENCE, expanding the clinical biomarker-driven ANAVEX2-73 rare disease program into additional late-stage studies with high unmet medical need, completing the late stage ANAVEX2-73 Phase 2b/3 Alzheimer’s disease trial, and advancing ANAVEX2-73 into clinical disease modifying testing in Parkinson’s disease."

Key Clinical Updates:

Plan to advance the AVATAR adult Rett syndrome study into a pivotal Phase 2/3 clinical trial.
Pipeline expansion for ANAVEX2-73 using gene biomarkers of response, applying precision medicine for neurological disorders with unmet medical need:
Planned initiation of a pivotal Phase 2/3 study in Fragile X Syndrome, the most frequent genetic cause of autism spectrum disorder.
Planned initiation of a Phase 2/3 clinical trial for the treatment of a new, rare-disease indication.
Phase 2b/3 ANAVEX2-73 Alzheimer’s disease (AD) study currently over 80% enrolled with complete enrollment expected in early 2021.
Planned initiation of ANAVEX2-73 imaging-focused Parkinson’s disease clinical study.
Recent Business Highlights:

In December 2020, Anavex announced top-line results from a U.S. Phase 2 controlled trial of ANAVEX2-73 in adult female patients with Rett syndrome. Primary safety, pharmacokinetics and secondary efficacy endpoints were met, with statistically significant and clinically meaningful consistent improvements in Rett Syndrome Behaviour Questionnaire (RSBQ) and Clinical Global Impression Improvement (CGI-I) scores. Improvements in RSBQ Total scores were correlated with decreases (improvements) in plasma glutamate. Based on the results, Anavex is planning to meet with the FDA to discuss an accelerated approval pathway.
In November 2020, Anavex presented data at the 13th Clinical Trials on Alzheimer’s Disease (CTAD) 2020 Conference, reporting top-line results from the proof-of-concept Phase 2 placebo-controlled trial with primary objectives of safety, tolerability, and efficacy in cognition of ANAVEX2-73 in patients in Parkinson’s disease dementia (PDD) compared to placebo. Both primary objectives of the study were met. The results show clinically meaningful, dose-dependent, and statistically significant improvements in the Cognitive Drug Research (CDR) computerized assessment system analysis. The study confirmed the precision medicine approach of targeting SIGMAR1 as a genetic biomarker in response to ANAVEX2-73 supporting progression to further development in upcoming Phase 2/3 studies.
In November 2020, Anavex received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its patent application number 16/717,921 expected to remain in force at least until 2037, expanding coverage of treatment methods using its lead drug candidate, ANAVEX2-73, as well as drug candidate ANAVEX1-41 for treating a range neurodevelopmental disorders including Rett syndrome, autism spectrum disorder, Angelman syndrome, cerebral palsy and multiple sclerosis, among other indications.
Financial Highlights:

Cash and cash equivalents of $47.6 million as of today and $29.2 million at September 30, 2020, compared to $22.2 million at September 30, 2019.
Net loss of $26.3 million, or $0.45 per share for the year, compared to net loss of $26.3 million, or $0.54 per share in fiscal 2019.
Research and development expenses of $25.2 million for the year, compared to $22.3 million for fiscal 2019.
General and administrative expenses of $5.9 million for the year, compared to $6.8 million for fiscal 2019.
The financial information for the fiscal year ended September 30, 2020 should be read in conjunction with the Company’s consolidated financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com.

Conference Call / Webcast Information

The live webcast of the conference call can be accessed online at View Source

To join the conference call, live via telephone, interested parties within the U.S. should dial, toll-free, 1 (866) 939-3921 and international callers should dial 1 (678) 302-3550. Please use confirmation number 50061077, followed by the pound sign (#).

A replay of the conference call will also be available on www.anavex.com.

Exact Sciences to participate in J.P. Morgan Healthcare Conference

On December 28, 2020 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will participate in the following conference and invited investors to participate by webcast (Press release, Exact Sciences, DEC 28, 2020, View Source [SID1234573274]).

J.P. Morgan Healthcare Conference
Presentation followed by a Q&A session on Wednesday, January 13, 2021 at 2:50 p.m. EST
The webcast can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.