On September 1, 2022 Novo Nordisk and Forma Therapeutics, Holdings Inc. (Nasdaq: FMTX) reported that they have entered into a definitive agreement under which Novo Nordisk will acquire Forma Therapeutics for USD 20 per share in cash, which represents a total equity value of USD 1.1bn (Press release, Novo Nordisk, SEP 1, 2022, View Source [SID1234628159]). Forma Therapeutics is a clinical-stage biopharmaceutical company focused on transforming the lives of patients with sickle cell disease (SCD) and rare blood disorders.

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The acquisition of Forma Therapeutics, including its lead development candidate, etavopivat, is aligned with Novo Nordisk’s strategy to complement and accelerate its scientific presence and pipeline in haemoglobinopathies, a group of disorders in which there is abnormal production or structure of the haemoglobin protein in the red blood cells.

"Novo Nordisk has worked for more than 40 years to develop and deliver transformative medicines to patients around the world with rare and devastating diseases. By adding Forma’s differentiated approach to address unmet needs for patients, we are taking a step forward in enhancing our sickle cell disease pipeline," said Ludovic Helfgott, executive vice president and head of Rare Disease at Novo Nordisk. "We have an ambition to build a leading portfolio with standalone and combination treatments to tackle the complications and underlying causes of sickle cell disease."

Etavopivat, an investigational oral, once-daily, selective pyruvate kinase-R (PKR) activator, is being developed to improve anaemia and red blood cell health in people with SCD, a seriously debilitating, life-threatening and life shortening disease. Etavopivat is currently being evaluated in a global phase 2/3 clinical trial (Hibiscus) in patients with SCD, and in a phase 2 trial (Gladiolus) in patients with transfusion-dependent SCD and another inherited haemoglobinopathy called thalassemia.

"Today’s announcement is an exciting milestone that accelerates Forma’s purpose to transform the lives of patients with sickle cell disease and other serious haematological diseases," said Frank D. Lee, president and chief executive officer of Forma. "Novo Nordisk will partner closely with the sickle cell community to amplify our impact for patients around the world who urgently need new treatment options. We look forward to working together with Novo Nordisk to serve as a trusted partner to our communities and to advance innovation, access and health equity for patients."

The transaction will not impact Novo Nordisk’s previously communicated operating profit outlook for 2022 or the ongoing share buy-back programme. Novo Nordisk will fund the acquisition from financial reserves.

About the transaction
Under the terms of the agreement, Novo Nordisk will initiate a tender offer to acquire all outstanding shares of Forma Therapeutics’ common stock at a price of USD 20 per share in cash (or aggregated value of USD 1.1bn) and a premium of 92% to Forma Therapeutics’ volume-weighted average price per share over the past 30 days ended August 31, 2022.

The transaction has been unanimously approved by the Forma Therapeutics Board of Directors. The closing of the tender offer will be subject to certain conditions, including the tender of shares representing a majority of Forma Therapeutics’ outstanding shares, receipt of applicable regulatory approvals and other customary conditions. Upon the successful completion of the tender offer, Novo Nordisk’s acquisition subsidiary will merge into Forma Therapeutics, and any shares of common stock of Forma Therapeutics not tendered into the offer will receive the same USD per share price payable in the tender offer. The transaction is expected to close in the fourth quarter of 2022.

In addition, certain affiliates of RA Capital Management, L.P., which collectively own approximately 19% of Forma Therapeutics’ outstanding shares, have entered into a support agreement pursuant to which they committed to tender their shares in the tender offer.

Novo Nordisk is represented by Moelis & Company UK LLP as financial advisor and Davis Polk & Wardwell LLP as legal advisor. Forma Therapeutics is represented by Centerview Partners LLC as financial advisor and Goodwin Procter LLP as legal advisor.

About sickle cell disease
Sickle cell disease (SCD) is a chronic and progressive inherited disorder associated with a decrease in the health and lifespan of red blood cells. People living with SCD have red blood cells that are crescent shaped, rendering them inflexible, fragile, and unable to effectively deliver oxygen. The health of these sickle red blood cells is impaired and characterized by reduced cellular energy, poor deformability, decreased membrane repair, and increased adhesion.

Around 17 million people worldwide live with SCD, including approximately 100,000 people in the United States, as well as approximately 30,000 in France, Germany, Italy, Spain, and the United Kingdom. SCD can cause serious health problems, including anemia, fatigue, episodes of pain known as vaso-occlusive crises (VOCs), and chronic, progressive end-organ damage. Despite recent advances in treatment, most patients with SCD still suffer from pain crises, lifelong disability, reduced quality of life, and shortened life expectancy.

About etavopivat
Etavopivat is an investigational, once-daily, selective pyruvate kinase-R (PKR) activator designed to be a disease-modifying therapy with the potential to improve red blood cell health and transform the lives of people living with SCD. Employing a multimodal approach, etavopivat works by activating the red blood cell’s natural PKR activity to decrease levels of the metabolite 2,3-DPG, allowing sickle hemoglobin to hold on to oxygen longer, resulting in decreased polymerization, haemolysis, and sickling. Etavopivat-mediated PKR activation also increases adenosine triphosphate (ATP) levels, to improve red blood cell function, which can lead to improved deformability, capacity for membrane repair, red blood cell health, and lifespan. Together, these effects are anticipated to improve the health of sickle red blood cell and lead to a reduction in anaemia, haemolysis, vaso-occlusive crises, and end organ damage.

In a phase 1 trial, etavopivat improved anaemia and red blood cell health and appeared to have a safe and well-tolerated profile, demonstrating a potential to improve the lives of patients with SCD, including increases in haemoglobin, improvements in red blood cell health, and decreases in vaso-occlusive crises (VOCs).

The U.S. Food and Drug Administration (FDA) has granted etavopivat Fast Track, Rare Pediatric Disease and Orphan Drug designations. Additionally, etavopivat was granted Orphan Drug designation from the European Commission based on a positive opinion from the Committee for Orphan Medicinal Products of the European Medicines Agency for the treatment of patients with SCD.

On September 1, 2022 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in the H.C. Wainwright 24th Annual Global Investment Conference (Press release, Kura Oncology, SEP 1, 2022, View Source [SID1234618869]). A pre-recorded presentation will be available to view on-demand beginning at 7:00 a.m. ET / 4:00 a.m. PT on September 12, 2022.

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The pre-recorded presentation will remain accessible for 90 days in the Investors section of Kura’s website at www.kuraoncology.com.

On September 1, 2022 VBL Therapeutics (Nasdaq: VBLT) ("VBL"), a biotechnology company developing targeted medicines for immune-inflammatory diseases, reported that VBL received a written notification (the "Notification Letter") from the Nasdaq Stock Market LLC ("Nasdaq") on August 31, 2022, notifying VBL that it is not in compliance with the minimum bid price requirement set forth in the Nasdaq Listing Rules for continued listing on the Nasdaq (Press release, VBL Therapeutics, SEP 1, 2022, View Source [SID1234618889]).

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Nasdaq Listing Rule 5450(a)(1) requires listed securities to maintain a minimum bid price of $1.00 per share, and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of the VBL’s ordinary shares for the 30 consecutive business days from July 20, 2022, to August 30, 2022, VBL no longer meets the minimum bid price requirement.

The Notification Letter does not impact the VBL’s listing on the Nasdaq Global Market at this time. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), VBL has been provided 180 calendar days, or until February 27, 2023, to regain compliance with Nasdaq Listing Rule 5450(a)(1). To regain compliance, VBL’s ordinary shares must have a closing bid price of at least $1.00 for a minimum of 10 consecutive business days. In the event VBL does not regain compliance by February 27, 2023, VBL may be eligible for an additional 180 day period to regain compliance or may face delisting.

VBL’s business operations are not affected by the receipt of the Notification Letter. VBL intends to monitor the closing bid price of its ordinary shares and may, if appropriate, consider implementing available options, including, but not limited to, implementing a reverse share split of its outstanding ordinary shares, to regain compliance with the minimum bid price requirement under the Nasdaq Listing Rules.

On September 1, 2022 Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported that Bill Lundberg, M.D., President, Chief Executive Officer of Merus, will participate in a panel discussion at Citi’s 17th Annual BioPharma Conference on Thursday, September 8, 2022 at 2:40 p.m. ET (Press release, Merus, SEP 1, 2022, View Source [SID1234618905]).

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The webcast of the panel discussion will be contemporaneously available on the Investors page of the Company’s website. The archived presentation will also be available there for a limited time after the event.

On September 1, 2022 Ibex Medical Analytics, the leader in AI-powered cancer diagnostics, reported outstanding outcomes for the Galen Breast solution in diagnosing multiple cancer types and further expansion of its AI portfolio for breast cancer diagnosis (Press release, Ibex Medical Analytics, SEP 1, 2022, View Source [SID1234618922]). The CE-Marked AI solution is generally available as Ibex partners with laboratories, hospitals and health systems across Europe to deploy Galen Breast into their routine workflow, supporting improved quality and efficiency in the diagnosis of breast biopsies.

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Breast cancer is the most common malignant disease in women worldwide, with over two million new cases each year. As such, accurate and timely diagnosis is key to guiding treatment decisions by oncologists and improving patient survival rates.

Over the last several years, rapid advances in personalized medicine have resulted in a growing complexity of cancer diagnosis. Coupled with the increase in overall cancer incidence and a global decline in the number of pathologists, these trends have led to growing workloads imposed on pathology departments. Clearly, there is a growing need for automated solutions and decision-support tools that help pathologists detect cancer to the utmost accuracy more rapidly.

Galen is Ibex’s integrated diagnostics platform supporting pathologists in the diagnosis of breast, prostate, and gastric biopsies. Galen is the most widely deployed AI technology in pathology, and laboratories, hospitals and health systems worldwide already use it as part of their everyday practice. The combination of a skilled pathologist together with the accuracy, speed and objectivity provided by Artificial Intelligence has the potential to improve the quality of diagnosis, user experience, operational efficiency, and ultimately patient outcomes.

Galen Breast demonstrated excellent outcomes in a blinded, multi-site clinical study at Institut Curie in France and Maccabi Healthcare Services in Israel. The study evaluated the performance of pathologists who used Ibex AI for diagnosing breast biopsies and compared them to pathologists who used only a microscope across multiple types of breast cancer including invasive and in-situ carcinoma as well as rare subtypes, such as metaplastic, mucinous, and other types of breast cancer. The study results showed very high accuracy and utility of Galen Breast across multiple scanning and staining platforms, and established its potential for improving the quality of diagnosis, compared to using a microscope alone. The full study results will be presented by Judith Sandbank, MD, Director of the Pathology Institute at Maccabi Healthcare Services5 and one of the principal investigators in the study, at the European Congress of Pathology which takes place in Basel, Switzerland, between September 3-7 (Ibex presents at booth no. 1).

Previous studies on Galen Breast established its AI algorithm’s accuracy in detecting cancer, distinguishing between multiple subtypes such as ducal and lobular carcinomas, grading DCIS (ductal carcinoma in-situ) and identifying rare tumors. Moreover, the solution successfully detected clinically important cancer-related and non-cancer features, including tumor infiltrating lymphocytes, angiolymphatic invasion, microcalcifications and more1,2. Galen also enables automated pre-ordering of the breast immunohistochemistry (IHC) panel and other tests which may help shorten the turnaround time for diagnosis of cancer cases, maximizing efficiency gains for laboratories and enabling patients to start treatment earlier3. Ibex is also working to expand its technology to support improved prognosis of breast cancer, by providing automated quantification of HER2, Ki67, ER and PR receptors in immunohistochemistry stained slides as part of its product portfolio. These innovative AI algorithms are intended to assist pathologists in their diagnosis which may help further enhance diagnostic efficiency and enable more accurate and objective scoring of breast biomarkers, allowing for improved treatment decisions and patient care.

"We are impressed with the successful study outcomes and the performance of Galen Breast, that was evaluated in a diagnostic setting which is identical to how our pathologists review cases in their daily routine," said Anne Vincent-Salomon, MD, Director of Pathology at Institut Curie and one of the principal investigators in the study4. "Our team demonstrated that when pathologists use Ibex’s AI technology they achieve very high accuracy levels in diagnosing breast cancer over a broad range of subtypes, with higher quality than when using a microscope alone. With these results, and as more and more laboratories transition to digital pathology workflows, I look forward to seeing Artificial Intelligence broadly adopted in the field."

"AI is going to be a critical adjunct to diagnostic pathology going forward. Pathologists reviewing whole-slide images, in combination with an AI algorithm, will provide better diagnoses and better care than either a pathologist alone or AI alone," said Stuart Schnitt, MD, Chief of Breast Oncologic Pathology at the Dana-Farber/Brigham and Women’s Cancer Center and Professor of Pathology at Harvard Medical School4. "AI has already demonstrated its value in helping pathologists improve the quality of breast cancer diagnosis and reduce misdiagnosis, and I am impressed with the outcomes of this new study, demonstrating the robustness and utility of Ibex AI in a primary diagnosis setting. I look forward to seeing the impact this solution will have on the overall performance of pathology departments and patient outcomes, as it becomes widely adopted."

"We are excited to announce this milestone results and enable breast pathologists to further adopt AI into their routine diagnosis of breast biopsies, following excellent outcomes in a clinical study" said Chaim Linhart, PhD, Co-founder and CTO of Ibex at Ibex Medical Analytics. "We believe that AI has an essential role to play in pathology and cancer diagnosis, extending beyond cancer detection to ultimately support pathologists across most of the diagnostic pathway, as demonstrated by the scope of clinical features available with Galen Breast, as well as the expansion toward automated quantification and scoring of breast biomarkers".