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Takeda Quarterly Financial Report for the Year Ended March 31, 2022

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Enveric Biosciences Announces Plans to Spin-off and Dividend its Cannabinoid Pipeline to Shareholders

On May 11, 2022 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a neuroscience-focused biotechnology company developing next-generation, psychedelic-inspired mental health medicines, reported plans to transfer and spin-off its cannabinoid clinical development pipeline assets to a wholly-owned subsidiary, Acanna Therapeutics Inc. ("Acanna"), by way of dividend to Enveric shareholders (Press release, Enveric Biosciences, MAY 11, 2022, View Source [SID1234614276]). The spin-off transaction will be subject to various conditions, including Acanna meeting the qualifications for listing on The Nasdaq Stock Market, and if successful, would result in two standalone public companies.

Dr. Joseph Tucker, CEO of Enveric Biosciences, commented, "In these challenging markets, the Board and Management team have spent considerable time evaluating the best way to create additional value for all stakeholders – patients, shareholders, and employees. We believe it would be in the best interest of our shareholders to spin-off 100% equity ownership of our cannabinoid clinical development pipeline. Upon completion of the proposed transaction, each resulting public company would be able to focus all its resources on the development of its respective pipeline assets, enabling, we anticipate, greater opportunity for product development success."

Acanna has secured an initial $1MM from an investor in a Series A Convertible Preferred Stock and Warrant financing. Under the terms of the investment, Acanna will, subject to certain other conditions, receive an additional $4MM upon completion of the spin-off into an independent, separately traded public company listed on The Nasdaq Stock Market. Following the spin-off and the investment of an aggregate of $5MM, that investor is expected to hold 25% of Acanna and warrants to acquire additional shares. Palladium Capital Group acted as a financial advisor to Enveric. Please see the Current Report on Form 8-K filed by Enveric on May 11, 2022, for further details.

Dr. Tucker continued, "For Enveric and Acanna, this spin-off transaction would allow each company to commit 100% of its efforts and capabilities towards developing its respective drug candidate portfolio. For Enveric, going forward, we intend to focus on mental health. We believe that Enveric’s achievements in the last year, including preparations for a clinical trial, positive preclinical data, and ongoing expansion of our drug candidate portfolio, the Psybrary, position us well for the future."

Strategic Rationale for Spinoff
The Company believes that spinning off the cannabinoid assets will allow Enveric and Acanna to maximize long-term value for all stakeholders. Following the proposed transaction, both Enveric and Acanna intend to:

Have separate, focused management teams with the knowledge and skills to deploy appropriate strategies and meet the unique requirements for each company’s operations.
Allocate capital more efficiently and strategically to develop their respective assets further.
Provide unique investment characteristics of interest to the capital markets.

Vaccitech Reports First Quarter 2022 Financial Results and Recent Corporate Developments

On May 11, 2022 Vaccitech plc (NASDAQ: VACC) reported its financial results for the first quarter ended March 31, 2022, and provided an overview of the Company’s recent corporate developments (Press release, Vaccitech, MAY 11, 2022, View Source [SID1234614262]). Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases, autoimmunity, and cancer .

"We’ve already made solid progress across the Company this year and are excited to share our plans to advance our recently acquired SNAPvax platform into the clinic in multiple disease indications including HPV cancer and celiac disease," said Bill Enright, Vaccitech’s CEO. "These are devastating diseases where we believe this novel platform provides a unique opportunity for potential cures. In addition, we expect to announce efficacy data in our chronic infectious disease programs in both HBV and HPV later this year. Finally, the royalty and milestone payments that we have begun to receive related to the sales of AstraZeneca’s SARS CoV2 vaccine will contribute non-dilutive capital to these efforts."

First Quarter 2022 and Recent Corporate Developments

·On April 6, 2022, the Company announced the notification of the commencement of royalty payments relating to commercial sales of Vaxzevria. The Company’s share of milestone and royalty payments received by OUI from AstraZeneca in the first quarter of 2022 amounted to $15.0 million.

·In April, the Company launched a program in HPV-associated cancer utilizing the SNAPvax platform and moved forward with an immunotherapeutic designed to induce regulatory T cells in patients with celiac disease. IND applications are expected to be filed for both programs during the first quarter of 2023.

·On April 29, 2022, the Company received scientific advice from the EMA defining a licensure pathway for the candidate MERS vaccine, VTP-500, which allows the Company to estimate expenses of the development pathway more accurately.

Upcoming Milestones

·In the second quarter of 2022, the Company expects to present additional Phase 1b/2a interim efficacy data on VTP-300 in patients with chronic HBV infection at the European Association for the Study of the Liver (EASL) International Liver Congress on June 22 to 26, 2022, which is also expected to be followed by full efficacy data in the second half of this year.

·In the third quarter of 2022, the Company expects to initiate dosing in a Phase 1/2 clinical trial of VTP-850 in patients with prostate cancer.

·In the fourth quarter of 2022, the Company intends to conduct an interim efficacy review of HPV001, a Phase 1b/2 clinical trial of VTP-200, a potential non-invasive treatment for low grade HPV-related cervical lesions.

First Quarter 2022 Financial Highlights:

·Cash position: As of March 31, 2022, cash and cash equivalents were $200.6 million, compared to $214.1 million as of December 31, 2021. The decrease in cash was primarily due to $6.6 million of net cash being used in operating activities and a $5.6 million negative effect of exchange rates on cash and cash equivalents.

·Research and development expenses: Research and development expenses were $10.7 million in the first quarter of 2022 compared to $4.6 million in the comparable period of the prior year. The increase in R&D expenses was primarily due to increased spending on the development of VTP-200, VTP-300, VTP-850 and VTP-600 and an increase in R&D personnel-related costs.

·General and administrative expenses: General and administrative expenses were $3.7 million in the first quarter of 2022 compared to $1.8 million in the comparable period of the prior year. The first quarter of 2022 includes $4.3 million of personnel expenses, including a share-based payment charge of $3.1 million, and a $5.3 million unrealized foreign exchange gain on revaluation of Company’s cash balances. Net of this gain, the increase in general and administrative expenses between the periods was mainly attributable to higher personnel costs, reflecting an increase in the Company’s headcount over the period, and higher insurance costs associated with operating as a public company.

·Net Income: For the first quarter of 2022, the Company generated a net income of $2.6 million, or $0.07 per share on both basic and fully diluted bases, compared to a net loss of $15.4 million, or $1.90 per share on both basic and fully diluted bases, for the comparable period of the prior year.

VolitionRx Limited Announces First Quarter 2022 Financial Results and Business Update

On May 11, 2022 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the first quarter ended March 31, 2022 (Press release, VolitionRX, MAY 11, 2022, View Source [SID1234614261]). Volition management will host a conference call tomorrow, May 12 at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details can be found below.

"I am delighted with the progress we are making, and in particular could not be prouder of the team’s achievement in securing a global licensing and supply agreement for our Nu.Q Vet Cancer Screening Test with Heska Corporation, one of the industry’s leading companies," commented Cameron Reynolds, President and Chief Executive Officer of Volition. "In April, we expanded our geographic footprint with the launch of the Nu.Q Vet Cancer Test in Singapore through SAGE Healthcare. We have also made good progress in other key areas including our Nu.Q NETs and Nu.Q Capture programs as we shift gears towards our goal of becoming a commercial company with a wide range of world class products."

Volition is hosting a Capital Markets Day at the New York Stock Exchange, in a hybrid format, on Friday, May 13, 2022, at 10 a.m. U.S. Eastern Time. Volition’s executive team will provide strategic updates and discuss the Company’s key short-term growth drivers. Details for this event can be found below.

An interview with Cameron Reynolds, President and Group Chief Executive Officer of Volition.

Company Highlights

Financial

Cash and cash equivalents as of March 31, 2022, totaled approximately $23.7 million compared with $20.6 million as of December 31, 2021.

On March 30th Volition received a $10 million milestone payment from Heska Corporation.

Net loss for the quarter was $7.7 million dollars compared to $6.1 million for the three-months ended March 31, 2021.

Personnel/ Operational

To support our commercial expansion of Nu.Q Vet we welcomed Daniel Sheres, Product Manager, Devin DeVoue, Marketing Manager and Kristy Valdivia, Global Accounts Manager to the Volition Veterinary Team.

Subsequent to quarter end we appointed Sharon Ballesteros as U.S. Head of Quality and Development Process.

Volition Veterinary

Executed a global licensing and supply agreement with one of the industry’s leading companies, Heska Corporation.

In exchange for granting Heska exclusive worldwide rights to sell the Nu.Q Vet Cancer Screening Test for companion animals at the Point of Care, Volition has received a $10 million upfront payment and is eligible to receive up to a further $18 million based upon the achievement of near/mid-term milestones.

In addition to these milestone payments Volition expects to receive ongoing revenue for the supply of key components for said exclusive point of care product(s).

Volition has also granted Heska non-exclusive rights to sell the Nu.Q Vet Cancer Screening Test in kit format for companion animals, through Heska’s network of central reference laboratories for which Volition will receive ongoing additional revenue for such kit sales.

This is a long-term deal with significant market and revenue potential for Volition through the sale of kits and key components.

Subsequent to the quarter end SAGE Healthcare launched our Nu.Q Vet Cancer Test in Singapore.

We are in advanced negotiations with other potential licensing partners in our efforts to make Nu.Q Vet products as accessible as possible worldwide and anticipate further announcements in 2022.

Nu.Q Capture

Nu.Q Capture, when used in combination with either sequencing, mass spectrometry and/or Volition’s Nu.Q assays could potentially aid diagnosis, treatment selection, and both treatment and disease monitoring in addition to aiding biomarker discovery.

The Nu.Q Capture program now has several strands of technology which:

essentially remove background noise, thereby amplifying the signal,

look to identify the signal in a novel way including through mass spectrometry, or

isolate various chromatin fragments, including nucleosomes and transcription factors.

Subsequent to the quarter end Volition sponsored a GenomeWeb webinar entitled "Novel Proteomics Approach to Epigenetic Profiling of Circulating Nucleosomes" featuring Professor Axel Imhof. To watch on demand, visit the GenomeWeb website.

Volition is developing a large 1000-plus patient Nu.Q Capture study in lung cancer and colorectal cancer with further announcements expected in 2022.

Upcoming Milestones

Drive near term revenue in the following key areas:

Licensing of its technology, with a particular but not exclusive focus on Nu.Q Vet.

Complete Heska Corporation agreement milestones in order to receive further milestone payments.

Sales of key components of Point of Care test with Heska.

Sales of kits from non-exclusive agreements for the use of Nu.Q Vet via central reference labs.

Ongoing and new Nu.Q Discover agreements.

Sales of its disease monitoring tests (e.g. COVID-19, sepsis).

Continue to progress the research program for the use of Nu.Q in NETosis, in monitoring disease progression of COVID-19, sepsis, and potentially other diseases and as a possible companion diagnostic for a treatment for sepsis.

Continue to advance its previously announced large-scale blood, lung, and colorectal cancer trials in Europe, Asia, and the U.S.

Publish several abstracts and peer-reviewed scientific papers with clinical results showing the robustness and utility of its Nu.Q platform.

Advance the development of Nu.Q Capture.

Continue to file patents to expand and extend its intellectual property portfolio.

Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with Terig Hughes, Chief Financial Officer of Volition, Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC, and Scott Powell, Executive Vice President, Investor Relations of Volition. The call will provide an update on important events which have taken place in the first quarter of 2022 and upcoming milestones.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source In addition, a telephone replay of the call will be available until May 25, 2022. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 10167203.

The event will be webcast and the presentations will be posted to Volition’s website. A replay will be made available.

Black Diamond Therapeutics Reports First Quarter 2022 Financial Results and Provides Corporate Update

On May 11, 2022 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, Black Diamond Therapeutics, MAY 11, 2022, View Source [SID1234614260]).

"We continue to build a pipeline of novel MasterKey therapies with our product candidates, including BDTX-1535 and BDTX-4933, and we are focused on delivering development candidates generated from our MAP drug discovery engine as we work to address major unmet needs of oncology patients. With our recently announced pipeline prioritization and realignment of resources to strengthen our financial position, we believe Black Diamond is well-positioned for strong execution across our upcoming clinical and preclinical milestones into the third quarter of 2024," said David Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "We are incredibly pleased with the pace at which our BDTX-1535 Phase 1 study has been advancing with the recently announced first patient dosed. This next generation brain-penetrant inhibitor of oncogenic EGFR represents a unique opportunity to potentially address existing gaps in the treatment landscape for patients with EGFR mutant NSCLC and GBM and we look forward to providing a clinical update for the program in 2023."

Recent Developments

BDTX-1535:

BDTX-1535 is designed as a potent, selective, irreversible and brain-penetrant MasterKey inhibitor of epidermal growth factor receptor (EGFR) mutations expressed in GBM and of intrinsic and acquired resistance EGFR mutations to third generation EGFR inhibitors in NSCLC.
In April 2022, the first patient was dosed in the Phase 1, global study of BDTX-1535.
The Company expects to provide a clinical update on BDTX-1535 in 2023.
BDTX-4933:

BDTX-4933 is a brain-penetrant BRAF inhibitor against families of Class I, II, III canonical and non-canonical mutations being developed for the treatment of patients with or without brain tumors. BDTX-4933 is designed to be highly selective and potent, with the ability to avoid paradoxical activation.
Black Diamond initiated investigational new drug (IND)-enabling studies in the first quarter of 2022 and expects to submit an IND application for BDTX-4933 with the U.S. Food and Drug Administration (FDA) in the first half of 2023.
Discovery-Stage Pipeline:

Black Diamond continues to leverage its Mutation-Allostery-Pharmacology, or MAP, drug discovery engine to advance its discovery-stage pipeline and anticipates progressing its fibroblast growth factor receptor (FGFR) program towards a development candidate nomination in 2022, in addition to disclosing a development candidate against a new target in 2023.
Corporate:

In April 2022, Black Diamond announced plans to realign its resources to prioritize research and development programs for BDTX-1535, BDTX-4933 and discovery efforts, and decided to discontinue the development of BDTX-189 and reduce its workforce by approximately 30% to extend its cash runway into the third quarter of 2024.
In March 2022, Black Diamond appointed Wendy L. Dixon, Ph.D. to its Board of Directors, who joined the Board with over 40 years of biopharmaceutical industry experience, including service as a member of the board of several publicly traded biopharmaceutical companies.
In February 2022, Black Diamond appointed Elizabeth Montgomery as its Chief People Officer, who joined the Company with nearly 20 years of expertise and experience in developing strong corporate culture at a number of life sciences organizations.
Financial Highlights

Cash Position: Black Diamond ended the first quarter of 2022 with approximately $179.7 million in cash, cash equivalents, and investments compared to $209.8 million as of December 31, 2021. Net cash used in operations was $28.6 million for the first quarter of 2022 compared to $100.1 million for the year ended December 31, 2021.
Research and Development Expenses: Research and development (R&D) expenses were $17.8 million for the first quarter of 2022 compared to $22.8 million for the first quarter of 2021. The decrease in R&D expenses was primarily due to reduced activities on the BDTX-189 program and reduced spending on early discovery projects.
General and Administrative Expenses: General and administrative (G&A) expenses were $7.9 million for the first quarter of both 2022 and 2021.
Net Loss: Net loss for the first quarter of 2022 was $25.5 million, as compared to $30.3 million for the same period in 2021.
Financial Guidance

Following the Company’s pipeline prioritization and workforce realignment announcement in April 2022, Black Diamond has extended its cash runway which is expected to be sufficient to fund its anticipated operating expenses and expenditure requirements into the third quarter of 2024.