On May 10, 2022 Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that it has entered into a clinical trial collaboration agreement with Oslo University Hospital (OUS) to run a phase 1/2 study testing polyvalent mutant RAS vaccine TG01 in multiple myeloma (MM) following standard of care (SoC) therapy (Press release, Targovax, MAY 10, 2022, View Source [SID1234614005]).

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Oncogenic mutations in the RAS family of genes drive up to 30% of all cancers and remain a major unmet medical need with few good treatment alternatives. Targovax was recently awarded two prestigious research grants from Innovation Norway and the Norwegian Research Council, totaling NOK 18m, to advance its TG mutant RAS cancer vaccine program. These grants include funding towards several clinical studies, of which the first to open will be a TG01 phase 1/2 trial in MM patients with relevant KRAS and NRAS mutations (approx. 15-20% of MM patients) to be run in Oslo, Norway.

The trial is a collaboration between OUS and Targovax and will test TG01 vaccination as a monotherapy in 20 KRAS or NRAS mutated MM patients who continue to have measurable disease after completion of SoC treatment. The aim is to assess whether anti-RAS T-cell priming induced by TG01 can enhance the clinical response. OUS will sponsor and be responsible for running and funding the trial, with Dr. Schjesvold as the principal investigator. Targovax will provide TG01 drug supply, scientific support and financial contribution.

Dr. Fredrik Schjesvold, Founder and Leader Oslo Myeloma Center, at Oslo University Hospital, and President of the Nordic Myeloma Study Group, said: "RAS-mutant multiple myeloma has poor prognosis and there are currently no available targeted treatment options for this patient population. Prior data clearly demonstrates the capability of TG01 to induce robust anti-RAS T-cell responses and eliminate residual disease in cancer patients, and suggest that TG vaccination could be a valuable tool to deepen and prolong responses in multiple myeloma. Being a Norwegian product makes it particularly interesting, and we very much look forward to collaborating with Targovax to test this concept in practice at our center."

Earlier in 2022, Targovax announced a collaboration with Agenus to utilize their proprietary vaccine adjuvant QS-21 STIMULON as an immune-stimulatory component of the TG vaccines for future development and commercialization. QS-21 has consistently demonstrated powerful antibody and cell-mediated immune responses both in cancer trials and commercially as a component of the Shingrix and Mosquirix vaccines. QS-21 should further potentiate the TG vaccines by driving stronger anti-RAS T-cell responses. The OUS trial will be the first study in patients of TG01 adjuvanted by QS-21.

Dr. Erik Digman Wiklund, Chief Executive Officer of Targovax ASA, added: "Following promising data from the first generation TG01 vaccine in pancreatic cancer, we have focused on enhancing our mutant RAS platform and establishing a cost-efficient, collaborative development plan to bring the program forward. We are now ready to bring TG01 back into the clinic in a new and improved format and are excited to work with Dr. Schjesvold and his team to assess the potential of TG01 in multiple myeloma. This trial will be the first step in a broader exploratory program with multiple collaboration partners aimed at testing TG01 vaccination in various RAS mutant cancer types and treatment combinations."

On May 10, 2022 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company" or "we") reported its first-quarter 2022 financial results (Press release, Bausch Health, MAY 10, 2022, View Source [SID1234614049]).

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"Our organic3 growth in the first quarter of 2022 was stable compared to the same quarter last year, despite incremental macro pressures and a challenging supply chain environment," said Thomas J. Appio, incoming chief executive officer ("CEO"), Bausch Health. "Following the closing of the initial public offering of the Bausch + Lomb eye health business later today, we will operate as two companies, which enables Bausch Health to increase its focus on accelerating growth with strategic commercial investments and expanding our pipeline with innovative products that improve the quality of life for patients around the world."

Bausch + Lomb Launches IPO and Begins Trading Under "BLCO" Ticker; Bausch Health Will Separate Chairman and CEO Roles
Bausch Health’s eye health business, Bausch + Lomb, which launched its initial public offering ("IPO") and subsequently began trading under the ticker "BLCO" on May 6, 2022, expects the IPO to close today, May 10, 2022. Bausch + Lomb remains on track to spin off from Bausch Health, following the expiry of customary lock-ups related to the IPO, achievement of target net leverage ratios and subject to market conditions, receipt of applicable shareholder and other necessary approvals.2 The Company expects to close the IPO with $630 million in gross proceeds to be applied for the repayment of Bausch Health’s long-term debt on May 10, 2022.

Mr. Appio will assume the role of CEO of Bausch Health, effective upon the closing of the IPO of Bausch + Lomb. The Company also separated the roles of chairman and CEO, with Joseph C. Papa remaining as Chairman until the full separation of Bausch + Lomb. Mr. Papa will be succeeded by Robert N. Power.4

1 This is a non-GAAP measure or a non-GAAP ratio. For further information on non-GAAP measures and non-GAAP ratios, please refer to the "Non-GAAP Information" section of this news release. Please also refer to tables at the end of this news release for a reconciliation of this and other non-GAAP measures to the most directly comparable GAAP measure.
2 The Bausch + Lomb common shares have been approved for listing on the New York Stock Exchange ("NYSE") and conditionally approved for listing on the Toronto Stock Exchange ("TSX"). The common shares began trading on the NYSE and on an "if, as and when issued basis" on the TSX on May 6, 2022; and the IPO is expected to close on May 10, 2022, subject to customary closing conditions.
3 Organic growth/change, a non-GAAP ratio, is defined as a change on a period-over-period basis in reported revenues on a constant currency basis (if applicable) excluding the impact of recent acquisitions, divestitures and discontinuations.
4 All leadership and board appointments are conditional and effective upon the closing of the IPO of Bausch + Lomb.

First-Quarter 2022 Revenue Performance
Total reported revenues were $1.918 billion for the first quarter of 2022, as compared to $2.027 billion in the first quarter of 2021, a decrease of $109 million, or 5%. Excluding the unfavorable impact of foreign exchange of $41 million and the impact of divestitures and discontinuations of $72 million, primarily due to the divestiture of Amoun Pharmaceutical Company S.A.E. ("Amoun") on July 26, 2021, revenue was flat organically1,3 when compared to the first quarter of 2021.

Revenues by segment were as follows:

Salix Segment
Salix segment reported and organic1,3 revenues were $464 million for the first quarter of 2022, as compared to $472 million for the first quarter of 2021, a decrease of $8 million, or 2%. The decrease was primarily driven by lower volumes due to the loss of exclusivity of certain products, partially offset by increased sales of XIFAXAN (rifaximin), TRULANCE (plecanatide) and PLENVU (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution), which grew by 1%, 14% and 60%, respectively, compared to the first quarter of 2021.

International Segment5
International segment reported revenues were $244 million for the first quarter of 2022, as compared to $306 million for the first quarter of 2021, a decrease of $62 million, or 20%. Excluding the unfavorable impact of foreign exchange of $12 million and the impact of divestitures and discontinuations of $69 million, primarily due to the divestiture of Amoun on July 26, 2021, International segment revenues increased organically1,3 by 8% compared to the first quarter of 2021.

Diversified Products Segment5
Diversified Products segment reported and organic1,3 revenues were $249 million for the first quarter of 2022, as compared to $296 million for the first quarter of 2021, a decrease of $47 million, or 16%, primarily attributable to a decrease in volumes, partially offset by an increase in net realized pricing.

___________________________________
5 Commencing in the first quarter of 2022, the Company realigned its segment reporting structure and now operates in the following reportable segments: Salix, International, Diversified Products, Solta Medical and Bausch + Lomb. Under the new segment structure, Ortho Dermatologics is now part of the current Diversified Products segment and the Solta reporting unit is now the sole reporting unit of the Solta Medical segment.
6 To assist investors in evaluating the Company’s performance, reported sales are adjusted for changes in foreign currency exchange rates. Change at constant currency, a non-GAAP ratio, is determined by comparing 2022 reported amounts adjusted to exclude currency impact, calculated using 2021 monthly average exchange rates, to the actual 2021 reported amounts.

Solta Medical Segment5
Solta Medical segment reported and organic1,3 revenues were $72 million for the first quarter of 2022, which was flat with the first quarter of 2021, which reflects an increase in net realized pricing, offset by a decline in volumes primarily due to inventory shortfalls resulting from the impact of lockdowns in China due to the new COVID-19 variant and microchip supply chain constraints.

Bausch + Lomb Segment5
Bausch + Lomb segment reported revenues were $889 million for the first quarter of 2022, as compared to $881 million for the first quarter of 2021, an increase of $8 million, or 1%. Excluding the unfavorable impact of foreign exchange of $29 million and the impact of divestitures and discontinuations of $3 million, the Bausch + Lomb segment increased organically1,3 by approximately 5% compared to the first quarter of 2021, primarily due to higher sales in the global Vision Care business, including LUMIFY (brimonidine tartrate ophthalmic solution 0.025%), Biotrue Multi-Purpose Solution and Ocuvite/PreserVision, and higher sales in the Global Surgical business.

Operating Results
Operating income was $285 million for the first quarter of 2022, as compared to an operating loss of $221 million for the first quarter of 2021, a favorable change of $506 million, primarily driven by a goodwill impairment charge of $469 million in our Ortho Dermatologics business that occurred in the first quarter of 2021, a decrease in asset impairments, including the loss associated with the sale of Amoun on July 26, 2021, and a decrease in amortization of intangible assets.

Net Loss
Net loss for the first quarter of 2022 was $69 million, as compared to $610 million for the first quarter of 2021, a favorable change of $541 million. The change was primarily due to the increase in operating results discussed above.

Adjusted net income (non-GAAP)1 for the first quarter of 2022 was $263 million, as compared to $370 million for the first quarter of 2021, a decrease of $107 million.

Cash from Operations
Cash used by operations was $63 million in the first quarter of 2022, as compared to cash generated from operations of $443 million in the first quarter of 2021, a decrease of $506 million. The decrease is primarily attributable to $349 million in payments of legacy legal settlements and the timing of payments in the ordinary course of business.

Earnings Per Share
GAAP Earnings Per Share ("EPS") Diluted for the first quarter of 2022 was ($0.19), as compared to ($1.71) for the first quarter of 2021.

Adjusted EBITDA (non-GAAP)1
Adjusted EBITDA (non-GAAP)1 was $732 million for the first quarter of 2022, as compared to $852 million for the first quarter of 2021, a decrease of $120 million, primarily due to the divestment of Amoun on July 26, 2021; increased Selling, General & Administrative expenses due to profit protection measures taken in the first quarter of 2021 to manage and reduce our operating expenses and preserve cash during the COVID-19 pandemic; and increased R&D spending.

Balance Sheet Highlights:
•First-quarter cash, cash equivalents, restricted cash and other settlement deposits were $2.460 billion7 on March 31, 2022
•Gross proceeds from the IPO2 of $630 million and from Bausch + Lomb’s debt financing of $2.5 billion are expected upon closing and will be used to reduce Bausch Health’s total long-term debt
•The Company’s availability under its 2023 Revolving Credit Facility was $1.171 billion at March 31, 2022

Select Company and Pipeline Highlights
•Launched XIPERE8 (triamcinolone acetonide injectable suspension), a therapy that uses the suprachoroidal space to treat patients suffering from macular edema associated with uveitis, in the United States
•Launched Bausch + Lomb ULTRA ONE DAY daily disposable silicone hydrogel contact lenses in 14 markets in Europe and Malaysia
•Reported revenues for Clear + Brilliant franchise increased by 27% during the first quarter of 2022 compared to the first quarter of 2021
•Published new data in Advances In Therapy on the cost impact of treating opioid-induced constipation with FDA-approved medications, including RELISTOR subcutaneous injection (methylnaltrexone bromide), in the Emergency Department
•To date, 83 patients have been enrolled in Phase 2 trial evaluating amiselimod (S1P modulator) for the treatment of mild to moderate ulcerative colitis
•Global enrollment continues in the Phase 3 trial evaluating the use of rifaximin SSD for the prevention of cirrhosis complications – hepatic encephalopathy, and the Company is preparing for regulatory meetings outside of the United States
•Received regulatory approval for LUMIFY (brimonidine tartrate ophthalmic solution 0.025%) and VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%, in Lebanon; VYZULTA is now approved in 17 countries

2022 Financial Outlook
Bausch Health updated its guidance for the full year of 2022 as follows:
•Full-Year revenue range of $8.25 – $8.40 billion, reaffirming organic1,3 growth of 3 – 5%
•Full-Year Adjusted EBITDA (non-GAAP)1 range of $3.225 – $3.375 billion, including $100 million of the previously disclosed $150 million annual run rate of dis-synergies

Other than with respect to GAAP Revenues, the Company only provides guidance on a non-GAAP basis. The Company does not provide a reconciliation of forward-looking Adjusted EBITDA (non-GAAP)1 to GAAP net income (loss), due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. Because deductions (such as restructuring, gain or loss on extinguishment of debt and litigation and other matters) used to calculate projected net income (loss)

vary dramatically based on actual events, the Company is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income (loss) at this time. The amount of these deductions may be material and, therefore, could result
___________________________________
7 Cash, cash equivalents, restricted cash and other settlement deposits includes restricted cash of $1.210 billion of payments into an escrow fund under the terms of a settlement agreement regarding certain U.S. securities litigation (subject to an objector’s appeal of the final court approval of the agreement).
8 In 2019, the Company acquired an exclusive license from Clearside Biomedical, Inc. for the commercialization and development of XIPERE in the United States and Canada.

in projected GAAP net income (loss) being materially less than projected Adjusted EBITDA (non-GAAP)1. These statements represent forward-looking information and may represent a financial outlook, and actual results may vary. Please see the risks and assumptions referred to in the Forward-looking Statements section of this news release.

On May 10, 2022 GeneCentric Therapeutics, a company making precision medicine more precise through RNA-based diagnostics, reported an upcoming presentation of initial results from the GARNER (Genomic Analysis of high-Risk Non-muscle invasive bladder cancer) real-world study at the 2022 American Urological Association (AUA) Annual Meeting, which is being held in New Orleans, Louisiana, May 13-16, 2022 (Press release, GeneCentric Therapeutics, MAY 10, 2022, View Source [SID1234614066]). In this moderated poster presentation, the frequency of fibroblast growth factor receptor (FGFR) alterations in high-risk non-muscle invasive bladder cancer (HR-NMIBC) and the association with bacillus Calmette-Guérin (BCG) outcome will be discussed.

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The GARNER Study is the largest HR-NMIBC real-world patient cohort ever assembled with both clinical and genomic detail and the first study of the broader GARNER Bladder Cancer Program. The study is a collaboration between the Department of Urology at Erasmus MC Cancer Institute (EMC), Janssen Research & Development, LLC (Janssen) and GeneCentric Therapeutics. The collaboration, led at EMC by Tahlita Zuiverloon, MD, PhD, Principal Investigator at the Erasmus MC Urothelial Cancer Research Group (EUCRG), involves retrospective longitudinal, genomic analysis of samples from a cohort of almost 600 NMIBC patients who underwent surgery and adjuvant BCG treatment.

"The initial results from the GARNER Study provide a comprehensive picture of FGFR alteration frequency and other findings and provides a deeper understanding of drivers of disease progression, as well as potential factors related to treatment response and failure or drug resistance," said Dr Zuiverloon. "We look forward to presenting the initial findings from the study with our collaborators at GeneCentric and Janssen as we continue to explore the complexities of FGFR in HR-NMIBC."

While topline clinicogenomic results from this study will be presented at AUA2022, further results will be presented as part of a subsequent publication.

Details regarding the presentation are provided below and will be available following the meeting at View Source

Title: Frequency of Fibroblast Growth Factor Receptor Alterations and Association with Bacillus Calmette-Guérin Outcomes in a Real-World Genomic Analysis of High-Risk Non-Muscle-Invasive Bladder Cancer (GARNER) Study

First Author: Tahlita C.M. Zuiverloon, MD, Department of Urology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands

On May 10, 2022 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a clinical-stage precision oncology company designing and developing novel targeted therapies for cancer treatment, reported financial results for the quarter ended March 31, 2022 and provided operational updates (Press release, Turning Point Therapeutics, MAY 10, 2022, View Source [SID1234614081]).

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"We are pleased with our continued progress led by our topline data for repotrectinib and now our third BTD being granted for our lead asset," said Athena Countouriotis, M.D., President and CEO. "We recently expanded our clinical pipeline with our first in-license of TPX-4589, our potential first-in-class ADC targeting Claudin18.2, which was recently granted Orphan Drug designation by the FDA for both gastric and pancreatic cancers. We continue to advance our pipeline including elzovantinib and look forward to a data-rich second half of the year, including updates from our repotrectinib and elzovantinib programs as well as a first look at our discovery program for KRAS G12D."

First quarter and recent operational highlights include:

REPOTRECTINIB, ROS1/TRK INHIBITOR

Announced that the U.S. Food and Drug Administration (FDA) granted an eighth regulatory designation, and third BTD, to lead drug candidate repotrectinib. BTD was granted for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with one ROS1 tyrosine kinase inhibitor and who have not received prior platinum-based chemotherapy (expansion cohort EXP-4 of the TRIDENT-1 study).
Reported positive topline blinded independent central review (BICR) data from all of the ROS1-positive advanced NSCLC cohorts from TRIDENT-1, utilizing a February 11, 2022 data cutoff date. Data in both TKI-naïve and TKI-pretreated cohorts are consistent with a potentially best-in-class drug candidate for patients with ROS1-positive advanced NSCLC.

In the ROS1-positive TKI-naïve advanced NSCLC population (EXP-1: n=71), the cORR was 79% (n=56/71; 95% CI: 68, 88), with 4 patients (6%) achieving a complete response (CR) and 52 patients (73%) achieving a partial response (PR). The cORR does not include one patient in an unconfirmed partial response (uPR) with tumor regression of -38% on the last scan, who remained on treatment awaiting the next scan as of the data cutoff date.

DOR ranged from 1.4+ to 35.1+ months with probability of patients in a response at 6, 9, 12 and 18 months reflected in Table 1 utilizing a Kaplan-Meier analysis, with a median duration of follow-up of 10.2 months.

Patients at Risk: Patients who have reached the specified timepoint without censoring or an event (progression or death).

PFS ranged from 0+ to 40.4+ months with probability of patients remaining progression free at 6, 9, 12 and 18 months reflected in Table 2 utilizing a Kaplan-Meier analysis, with a median duration of follow-up of 10.8 months.

οIn the ROS1-positive advanced NSCLC population pretreated with one prior TKI and prior platinum-based chemotherapy (EXP-2: n=26), the cORR was 42% (95% CI: 23, 63). Duration of response ranged from 3.6 to 18.3+ months.
οIn the ROS1-positive advanced NSCLC population pretreated with two prior TKIs without prior chemotherapy (EXP-3: n=18), the cORR was 28% (95% CI: 10, 54). Duration of response ranged from 1.9+ to 20.3+ months.
οIn the ROS1-positive advanced NSCLC population pretreated with one prior TKI without prior chemotherapy (EXP-4: n=56), the cORR was 36% (95% CI: 23, 50). The cORR does not include two patients with an uPR who both had tumor regressions of -47% on their last scans, both of whom remained on treatment awaiting their next scans as of the data cutoff date. Duration of response ranged from 1.9+ to 17.8 months.
Repotrectinib was generally well tolerated in a total of 380 patients with a safety and tolerability profile that was consistent with previously reported findings.
The TRIDENT-1 study continues to enroll patients globally and enrollment across all six cohorts of the study remains open and continues to progress steadily.
ELZOVANTINIB (TPX-0022), MET/SRC/CSF1R INHIBITOR

Phase 1 dose escalation completed utilizing intermediate dose level of 60 mg QD to 60 mg BID.
Patient enrollment continues in the SHIELD-1 study at 40 mg QD to 40 mg BID in Phase 1 dose expansion.
TPX-0046, RET INHIBITOR

Ongoing characterization of the pharmacokinetics, safety, and efficacy profile in the dose finding portion of the study before determining the recommended Phase 2 dose (RP2D).
TPX-0131, ALK INHIBITOR

Ongoing patient dosing in the Phase 1/2 FORGE-1 study of TPX-0131 in locally advanced or metastatic TKI-pretreated ALK-positive NSCLC.

TPX-4589, CLAUDIN18.2 ADC

Announced exclusive license agreement with LaNova Medicines to develop and commercialize TPX-4589 (LM-302), a novel, potentially first-in-class, antibody drug conjugate (ADC) targeting Claudin18.2 in the U.S. and rest of the world excluding Greater China and South Korea. Claudin18.2 is a protein expressed in many gastrointestinal cancers, including gastric, gastroesophageal, and pancreatic cancer. TPX-4589 (known in China as LM-302) is currently in Phase 1 clinical trials in both the U.S. and China.
Received two Orphan Drug designations (ODDs) from the FDA in the first quarter of 2022. ODDs were granted to LaNova Medicines for the treatment of pancreatic cancer and for the treatment of gastric cancer, including cancer of the gastroesophageal junction.
DISCOVERY

Continued advancement of internal discovery programs targeting aberrant GTPase signaling known to drive genomically defined cancers with significant unmet medical need. The most advanced programs target KRAS G12D and the p21 activated kinase, or "PAK" family. The company is targeting nomination of two development candidates in the second half of 2022 with a goal to achieve at least one new IND per year beginning in 2023.
Upcoming Milestones

REPOTRECTINIB

Discuss topline BICR data from all the ROS1-positive NSCLC cohorts from TRIDENT-1 with the FDA at a pre-NDA meeting in the second quarter of 2022.
Present detailed study results, including intracranial activity, from the ROS1-positive advanced NSCLC cohorts of the TRIDENT-1 study at a medical conference in the second half of 2022.
Provide a clinical data update from the NTRK+ advanced solid tumor cohorts from TRIDENT-1 in the second half of 2022.
ELZOVANTINIB

Initiate the Phase 1b/2 SHIELD-2 study of elzovantinib in combination with aumolertinib in mid-2022.
Initiate the Phase 2 portion of the SHIELD-1 study in the second half of 2022, pending FDA feedback on data from the intermediate dose level.
Provide a clinical data update from the Phase 1 SHIELD-1 study in the second half of 2022.
TPX-0131

Provide early interim data from initial patients treated in the dose-finding portion of the FORGE-1 study in the fourth quarter of 2022 or early 2023.
TPX-4589

Present preclinical data at a medical conference by early 2023.
Provide additional guidance on clinical development plan by early 2023.
DISCOVERY

Nominate 2 development candidates in the second half of 2022.
Provide details on the other 2 GTPase signaling discovery programs in the second half of 2022.
First Quarter 2022 Financial Results

Revenue: Revenue recognized during the three months ended March 31, 2022 was $0.4 million from the sale of clinical supply to Zai Lab for supporting the TRIDENT-1 Phase 2 clinical trials in the Zai Territory, compared to $25.2 million for the first quarter of 2021, consisting of $25.0 million related to an upfront payment received under the Zai Lab Elzovantinib Agreement and $0.2 million from the sale of clinical supply to Zai for TRIDENT-1.

R&D Expenses: Research and development expenses were $55.1 million for the first quarter compared to $41.3 million for the first quarter of 2021. Primary drivers of the year-over-year increase were investments made to develop repotrectinib, elzovantinib, discovery efforts and personnel expenses.

G&A Expenses: General and administrative expenses were $20.3 million for the first quarter compared to $20.0 million for the first quarter of 2021.

Net Loss: Net loss was $74.4 million for the first quarter compared to net loss of $35.5 million for the first quarter of 2021, which included revenue for $25 million as upfront payment related to Zai Lab collaboration agreement.

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2022 totaled $918.2 million, reflecting a net decrease of approximately $63 million from December 31, 2021. Turning Point projects its cash position is sufficient to fund current operations through the first half of 2024.

On May 10, 2022 Pfizer Inc. (NYSE: PFE) and Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) reported that the companies have entered into a definitive agreement under which Pfizer will acquire Biohaven, the maker of NURTEC ODT, an innovative dual-acting migraine therapy approved for both acute treatment and episodic prevention of migraine in adults (Press release, Pfizer, MAY 10, 2022, View Source [SID1234614097]).

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Under the terms of the agreement, Pfizer will acquire all outstanding shares of Biohaven not already owned by Pfizer for $148.50 per share in cash. Biohaven common shareholders, including Pfizer, will also receive 0.5 of a share of New Biohaven, a new publicly traded company that will retain Biohaven’s non-CGRP development stage pipeline compounds, per Biohaven common share. The boards of directors of both

Biohaven and Pfizer have unanimously approved the transaction. Pfizer will pay transaction consideration totaling approximately $11.6 billion in cash. Pfizer will also make payments at closing to settle Biohaven’s third party debt and for the redemption of all outstanding shares of Biohaven’s redeemable preferred stock. The $148.50 cash consideration represents a premium of approximately 33% to Biohaven’s volume weighted average selling price of $111.70 over the three months prior to the announcement of the transaction.

The proposed transaction includes the acquisition of Biohaven’s calcitonin gene-related peptide (CGRP) programs including:

Rimegepant:

Approved in the United States (U.S.) under the trade name, NURTEC ODT, for both the acute treatment of migraine and preventive treatment of episodic migraine

Approved in the European Union under the trade name, VYDURA, for both acute treatment of migraine and prophylaxis of episodic migraine

Zavegepant:

On track for a 2Q2022 acceptance (based on March 2022 submission) in the U.S. as an intranasal spray for the acute treatment of migraine and in development as an oral soft gel for chronic migraine prevention

A portfolio of five pre-clinical CGRP assets

"Today’s announcement builds on our legacy of delivering breakthroughs for patients living with complex pain disorders and diseases that disproportionately impact women," said Nick Lagunowich, Global President, Pfizer Internal Medicine. "NURTEC ODT, which is already the #1 prescribed migraine medicine in its class in the United States, coupled with Biohaven’s CGRP pipeline, offers hope for patients suffering from migraine worldwide. We believe Pfizer is uniquely positioned to help the portfolio reach its full potential given our leading scale and capabilities, including comprehensive field force engagement with Primary Care Physicians, specialists and health systems delivering the right information at the right time."

This agreement follows on the November 9, 2021 collaboration for the commercialization of rimegepant and zavegepant outside the United States, in connection with which Pfizer invested $350 million to acquire 2.6% of Biohaven’s common stock at $173 per share.

"We are excited to announce Pfizer’s proposed acquisition of Biohaven, recognizing the market leadership of NURTEC ODT, our breakthrough all in one migraine therapy, and the untapped potential of our CGRP franchise," said Vlad Coric, MD, Chairman and Chief Executive Officer of Biohaven. "Pfizer’s capabilities will accelerate our mission to deliver our migraine medicines to even more patients, while the new R&D company is well positioned to bring value to patients and shareholders by focusing on our innovative pipeline for neurological and other disorders. We believe this transaction represents significant future value creation for patients and our collective shareholders."

Following the closing, New Biohaven will continue to operate under the Biohaven name. New Biohaven will be led by Vlad Coric, MD, as Chairman and CEO, and include other members of the current management team of Biohaven. Biohaven common shareholders will receive, for each Biohaven share, 0.5 of a share of New Biohaven distributed via a pro rata distribution of SEC-registered, publicly listed shares. At distribution, New Biohaven will be capitalized with $275 million of cash. New Biohaven will also have the right to receive tiered royalties from Pfizer on any annual net sales of rimegepant and zavegepant in the United States in excess of $5.25 billion.

Pfizer expects to finance the transaction with existing cash on hand.

Pfizer’s acquisition of Biohaven is subject to the completion of the New Biohaven spin-off transaction and other customary closing conditions, including receipt of regulatory approvals and approval by Biohaven’s shareholders. The companies expect the transaction to close by early 2023.

Due to the proposed transaction, Biohaven will not hold a conference call to discuss its first quarter 2022 financial results and will issue a press release and file a quarterly report on Form 10-Q with the U.S. Securities and Exchange Commission announcing those results on May 10, 2022.

J.P. Morgan acted as Pfizer’s financial advisor for the transaction with Ropes & Gray LLP acting as its legal advisor. Centerview Partners acted as Biohaven’s financial advisor for the transaction with Sullivan & Cromwell LLP acting as its legal advisor.

Investor Call Details

Pfizer and Biohaven will host an analyst and investor call today at 10am EDT to discuss the proposed transaction.

Webcast Details | Pfizer Analyst and Investor Call | May 10

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About Migraine

Around one billion people suffer from migraine across the globe, of which 75 percent are women. The World Health Organization classifies migraine as one of the 10 most disabling medical illnesses. There is a large unmet need for new acute and preventive treatments, as a significant portion of migraine patients are unsatisfied with current standard of care migraine treatments due to a lack of efficacy or safety or tolerability burden.

About Rimegepant

Rimegepant targets a root cause of migraine by reversibly blocking CGRP receptors, thereby inhibiting the biologic cascade that results in a migraine attack. Rimegepant was approved by the U.S. Food and Drug Administration (FDA) under the trade name NURTEC ODT for the acute treatment of migraine in February 2020 and for the preventive treatment of episodic migraine in May 2021. In April 2022, the European Commission (EC) granted marketing authorization for VYDURA (rimegepant) for both the acute treatment of migraine with or without aura, and prophylaxis of episodic migraine in adults who have at least four migraine attacks per month. NURTEC ODT is the #1 prescribed migraine treatment in its class with a cumulative launch to date of U.S. net revenue of approximately $650 million and with more than two million prescriptions. A single dose of 75 mg NURTEC ODT provides fast pain relief, significant pain reduction and return to normal function, and has a lasting effect of up to 48 hours in some patients. NURTEC ODT is taken orally as needed, up to 18 doses/month to stop migraine attacks or taken every other day to help prevent migraine attacks and reduce the number of monthly migraine days. NURTEC ODT does not have addiction potential and is not associated with medication overuse headache or rebound headache.

About Zavegepant

Zavegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist from Biohaven’s NOJECTION Migraine Platform and the only CGRP receptor antagonist in clinical development with both intranasal and oral formulations. The efficacy and safety profile of intranasal zavegepant for the acute treatment of migraine, as compared to placebo, was shown in a randomized controlled Phase 2/3 dose-ranging trial with a total of over 1000 patients who received zavegepant. In this study, zavegepant showed statistical superiority to placebo on the coprimary endpoints of 2-hour freedom from pain and freedom from a patients’ most bothersome symptom (either nausea, photophobia or phonophobia). This was the second zavegepant pivotal clinical trial to meet these coprimary endpoints. Biohaven plans to file a new drug application with the U.S. Food and Drug Administration for zavegepant in the second quarter of 2022.

NURTEC ODT U.S. IMPORTANT SAFETY INFORMATION

NURTEC ODT (orally disintegrating tablet) is a prescription medicine that is used to treat migraine in adults. It is for the acute treatment of migraine attacks with or without aura and the preventive treatment of episodic migraine. It is not known if NURTEC ODT is safe and effective in children.

Do not take NURTEC ODT if you are allergic to NURTEC ODT (rimegepant) or any of its ingredients.

Before you take NURTEC ODT, tell your healthcare provider (HCP) about all your medical conditions, including if you:

have liver problems,

have kidney problems,

are pregnant or plan to become pregnant,

are breastfeeding or plan to breastfeed.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

NURTEC ODT may cause serious side effects including allergic reactions, including trouble breathing and rash. This can happen days after you take NURTEC ODT. Call your HCP or get emergency help right away if you have swelling of the face, mouth, tongue, or throat or trouble breathing. This occurred in less than 1% of patients treated with NURTEC ODT.

The most common side effects of NURTEC ODT were nausea (2.7%) and stomach pain/indigestion (2.4%). These are not the only possible side effects of NURTEC ODT. Tell your HCP if you have any side effects.

You are encouraged to report side effects of prescription drugs to the FDA. Visit View Source or call 1-800-FDA-1088 or report side effects to Biohaven at 1-833-4Nurtec.