On August 3, 2020 PMV Pharmaceuticals, Inc., a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutations, reported the completion of a $70 million Series D financing round. Avoro Capital, RA Capital Management and Wellington Management Company joined existing investors OrbiMed Advisors, Nextech Invest, Viking Global Investors, and Boxer Capital of Tavistock Group in the round (Press release, PMV Pharma, AUG 3, 2020, View Source [SID1234562779]).

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The proceeds will be used to advance PMV Pharma’s p53 product candidates. p53 is a tumor suppressor protein and the wild type, or normal, p53 protein plays a pivotal role in the body’s natural defense mechanism against cancer and induces a highly organized program of cellular death to prevent the proliferation of potentially cancerous cells.

Mutant p53 proteins can be misfolded and lose their wild type tumor suppressing function. p53 mutations are found in approximately half of all human cancers. PMV Pharma’s mechanism of action seeks to restore p53 to its normal, wild-type function, which could result in the selective killing of mutant cancer cells without affecting normal tissues.

"This financing provides PMV Pharma with the resources to expand our pipeline and to potentially advance multiple p53 therapies into the clinic," said David Mack, Ph.D., President and Chief Executive of PMV Pharma. "We are excited to have new and strong life science investors that include Avoro, RA Capital and Wellington join us in our pursuit of developing meaningful new medicines for cancer patients. The enthusiasm and confidence from our new and existing investors underscore the important advances we have made."

In addition, PMV Pharma announced the appointment of Rich Heyman, Ph.D. as Chair of the Board of Directors. An industry leader, entrepreneur and renowned scientist with a deep knowledge of and broad depth in the field of oncology, Dr. Heyman has more than 25 years of biopharma experience. He currently serves as Board Chair of ORIC Pharmaceuticals and is on the Board of Directors of Gritstone Oncology, Yumanity Therapeutics, Amunix Pharmaceuticals, Metacrine Inc., and Vividion Therapeutics.

Previously, Dr. Heyman was the co-founder and CEO of Aragon Pharmaceuticals and Seragon Pharmaceuticals, two biotech companies focused on discovering and developing therapeutics targeting hormone-dependent cancers. Johnson & Johnson purchased Aragon in 2013 and Genentech/Roche purchased Seragon in 2014.

"We are thrilled to have Rich join PMV Pharma’s Board of Directors as our Chair. His wealth of experience and proven track record of strategic business, scientific and clinical accomplishments will be invaluable as we continue to progress our pipeline of p53 programs towards the clinic," said Dr. Mack.

"PMV has made significant progress in designing small molecules that modulate p53 function, a well-known but previously inaccessible target in oncology," said Dr. Heyman. "The PMV team, its scientific founders and advisors have created potential therapies that could be first-in-class. I am excited to join as Chair of the Board and look forward to continuing to work with this talented team to help advance PMV’s p53 therapies."

On August 3, 2020 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, reported that it has entered into a securities purchase agreement with several institutional investors in the United States providing for the sale and issuance of approximately 12,427,876 common shares at a purchase price of $0.56325 per common share in a registered direct offering priced at-the-market under Nasdaq rules (Press release, AEterna Zentaris, AUG 3, 2020, View Source [SID1234562748]). The offering is expected to result in gross proceeds to Aeterna Zentaris of approximately $7.0 million.

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Aeterna Zentaris will also issue to the purchasers unregistered warrants to purchase up to an aggregate of 9,320,907 common shares. The warrants will be exercisable for a period of five and one-half years, exercisable immediately following the issuance date and have an exercise price of $0.47 per common share.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The Company intends to use the net proceeds of this offering for general corporate purposes, which includes, among other purposes, the funding of a pediatric clinical trial in the E.U. and U.S. for Macrilen (macimorelin), the investigation of further therapeutic uses of macimorelin and the expansion of pipeline development activities.

The registered direct offering and concurrent private placement is expected to close on or about August 5, 2020, subject to the satisfaction of customary closing conditions.

The common shares described above (but not the warrants or the common shares underlying the warrants) are being offered by Aeterna Zentaris pursuant to a "shelf" registration statement on Form F-3 (File No. 333-232935), which was previously declared effective by the U.S. Securities and Exchange Commission ("SEC") on August 15, 2019. Such common shares may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

A prospectus supplement relating to the common shares will be filed by Aeterna with the SEC. When filed with the SEC, copies of the prospectus supplement and the accompanying prospectus relating to the registered direct offering, may be obtained at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and accompanying prospectus relating to the registered direct offering may also be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996 or by email at [email protected].

The warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "Act"), and, along with the common shares issuable upon their exercise, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

On August 3, 2020 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported a strategic collaboration with Regeneron for a clinical trial combining BioNTech’s BNT111 FixVac product candidate and Libtayo (cemiplimab), a fully human anti-PD-1 therapy, for the treatment of melanoma (Press release, BioNTech, AUG 3, 2020, View Source [SID1234562743]). The companies plan to jointly conduct a randomized Phase 2 study in patients with anti-PD1-refractory/relapsed, unresectable Stage III or IV cutaneous melanoma. Melanoma is the deadliest skin cancer and estimated to kill more than 63,000 people around the world this year.1

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BNT111 is the most advanced of five clinical stage FixVac product candidates within BioNTech’s broader development pipeline. It is an mRNA cancer immunotherapy targeting four antigens frequently expressed in the tumors of patients with melanoma – NY-ESO-1, MAGE-A3, tyrosinase, and TPTE. BNT111 has demonstrated clinical anti-tumor activity as a monotherapy and in combination with checkpoint inhibitors in an ongoing Phase 1 trial in patients with advanced melanoma after prior checkpoint blockade.

"We believe our FixVac platform represents a powerful new drug class of mRNA immunotherapies against cancer. We look forward to working together with Regeneron to advance this product candidate into potentially registrational clinical trials," said Ugur Sahin, CEO and Co-founder of BioNTech.

The two companies plan to pursue a clinical trial for the combination in the second-line treatment setting for advanced melanoma. The companies plan to disclose more details related to the planned Phase 2 study in the third quarter of 2020, with the goal of initiating the trial in the fourth quarter of 2020.

"Despite recent treatment advances with anti-PD-1 therapies for patients with melanoma, most patients fail to obtain a durable benefit. The combination of Libtayo and BNT111 FixVac has the potential to augment the immune system’s ability to effectively recognize melanoma in multiple ways and hopefully improve immune targeting to control the cancer," said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational Science and Oncology, at Regeneron.

Under the terms of the agreement, development costs for the clinical trial will be shared equally and both companies will contribute their products for the trial. Each party will retain full commercial rights for its respective product and record revenues related to its own product.

Libtayo is being jointly developed by Regeneron and Sanofi.

On August 3, 2020 vTv Therapeutics Inc. (Nasdaq:VTVT) reported financial results for the second quarter ended June 30, 2020, and provided an update on the progress of its clinical programs (Press release, vTv Therapeutics, AUG 3, 2020, View Source [SID1234562742]).

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"Building on the successful phase 2 study completed earlier this year with TTP399, we have been highly focused on advancing this promising candidate as an adjunct to insulin for type 1 diabetes into the next stage of clinical development," said Steve Holcombe, president and CEO. "To this end, we have been engaging with the FDA to determine the development path for TTP399 and are in the planning stages for our first pivotal study, which we anticipate commencing by the end of 2020. We have also continued to enroll patients in our phase 2 study of azeliragon for the treatment of Alzheimer’s disease in patients with type 2 diabetes, despite the clinical challenges posed by COVID-19."

Recent Achievements and Outlook

Type 1 Diabetes

FDA Engagement and Pivotal Study Planning. Following a Type C Meeting request, vTv received written feedback from the FDA in June regarding the design of the Company’s proposed pivotal studies. vTv expects to commence the next study for TTP399 by the end of 2020 with a six-month treatment period and a six-month open label extension. A second study with a 6-month treatment period would be initiated within 12 months after initiation of the first trial.

Two Presentations at ADA of SimpliciT-1 Study Results. Dr. John Buse, University of North Carolina at Chapel Hill, and Dr. Carmen Valcarce, chief scientific officer, made separate presentations at the American Diabetes Association’s 80th Scientific Sessions on the results of the Simplici-T1 Study in which TTP399 improved HbA1c in patients with type 1 diabetes, while reducing insulin dose and lowering the incidence of hypoglycemia and diabetic ketoacidosis.

Dementia with Diabetes

Enrollment continues for Phase 2 Elevage Study of azeliragon. vTv continues to enroll patients in the Elevage Study to evaluate the efficacy and safety of azeliragon in patients with probable mild Alzheimer’s disease (AD) and type 2 diabetes. Recruitment for the study will conclude by September 30, 2020 with a target of approximately 50 patients enrolled. The Company expects to report topline results from this study in the second quarter of 2021.

Additional Clinical Data from STEADFAST Presented at AAIC. Dr. Aaron Burstein, SVP clinical development, presented additional clinical data at the Alzheimer’s Association International Conference of the impact of azeliragon on the individual

components of CDR-sb and ADAS-cog, the two primary instruments used to evaluate Alzheimer’s disease.

Financing Activities

During the second quarter, vTv entered into agreements in order to provide additional financial flexibility and availability of additional capital to fund its near-term operations.

Amendment to the Loan Agreement. On July 29, 2020, vTv entered into the Third Amendment to the Company’s existing Loan Agreement to allow monthly, interest-only payments on the outstanding principal balance for two additional months beginning July 1, 2020 and to extend the maturity date of the first tranche from August 1 to September 1, 2020. The Third Amendment also eliminates the requirement for the Company to maintain a minimum cash balance.

ATM Sales. Under the Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald, vTv sold shares of its Class A common stock having an aggregate offering price of $7.6 million as of the end of the second quarter.

Second Quarter 2020 Financial Results

Cash Position: The Company’s cash position as of June 30, 2020, was $6.4 million compared to $0.4 million as of March 31, 2020.

Revenue: Revenues were insignificant for both the first and second quarter of 2020.

R&D Expenses: Research and development expenses were $2.5 million and $4.2 million for the three months ended June 30, 2020 and March 31, 2020, respectively. This decrease of $1.7 million was driven primarily by a decrease of $0.5 million related to the development of TTP399, as the Simplici-T1 Study was completed in early 2020. Further, costs related to the development of azeliragon decreased approximately $0.8 million related to lower costs incurred for the Elevage Study due to a slowdown in enrollment caused, in part, by COVID-19.

G&A Expenses: General and administrative expenses were $1.7 million for the second quarter of 2020 and $2.5 million for the first quarter, respectively. The decrease of $0.8 million was driven by lower professional fees, an adjustment made to the Company’s asset retirement obligation recorded in connection with a leased facility, and overall expense curtailment.

Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $5.0 million for the second quarter of 2020 compared to $7.2 million for the first quarter of 2020.

Net Loss Per Share: GAAP net loss per share was $0.07 and $0.11 for the three months ended June 30, 2020 and March 31, 2020, respectively, based on weighted-average shares of 45.7 million and 43.5 million for the three-month periods ended June 30, 2020 and March 31, 2020, respectively. Non-GAAP net loss per fully exchanged share was $0.08 and $0.11 for the three months ended June 30, 2020 and March 31, 2020, respectively, based on non-GAAP fully exchanged weighted-average shares of 68.8 million

On August 3, 2020 Pacific Biosciences of California, Inc. (Nasdaq:PACB), a leading provider of high-quality sequencing of genomes, transcriptomes and epigenomes, and Asuragen, a molecular diagnostics company delivering easy-to-use products for complex testing in genetics and oncology, reported their clinical research collaboration aimed at developing molecular assays based on PacBio’s Single Molecule, Real-Time (SMRT) Sequencing technology (Press release, Pacific Biosciences, AUG 3, 2020, View Source [SID1234562722]). The initial focus of the collaboration will be on research in support of assay development for the carrier screening market.

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Several of the most common carrier genes for autosomal recessive and X-linked conditions are either technically challenging or inaccessible to amplify and sequence, leading to incomplete coverage and convoluted workflows spread over multiple platforms. Through this collaboration, Asuragen scientists will develop assays that combine the company’s AmplideX PCR technology for enriching hard-to-amplify sequences with PacBio SMRT Sequencing, a highly accurate long-read sequencing platform with a unique ability to represent all regions of the genome and to detect any kind of structural or other variation.

"Innovative amplification and sequencing technologies have each been instrumental in discovering and characterizing challenging disease-causing structural variants, such as indels, copy number changes, and repeat expansions," said Gary J. Latham, PhD, Senior Vice President of Research and Development at Asuragen. "We are excited to work with PacBio to combine the best of both technologies to build assays that can uniformly resolve simple and complex forms of genetic variation for research and clinical applications."

Scientists at Asuragen will develop assays for PacBio’s Sequel Systems using Asuragen’s AmplideX PCR technology. AmplideX products are designed to solve testing needs in inherited genetic disorders through easy-to-run assays and optimized workflows that deliver best-in-class performance. Assays will make use of PacBio’s HiFi long reads, an approach incorporating multiple passes of the same molecule to create a highly accurate consensus sequence.

"We are honored to partner with Asuragen, a leader in molecular diagnostics, to apply the unique value of SMRT Sequencing for clinical research," said Jonas Korlach, PhD, Chief Scientific Officer of Pacific Biosciences. "Scientists have shown that PacBio’s long-read sequencing systems offer a high-resolution view of the human genome that is simply not possible with any other sequencing technology. We look forward to working with Asuragen to design assays capable of interrogating challenging genomic regions and identifying the full breadth of natural human genetic variation."