On April 4, 2022 Herantis Pharma Plc ("Herantis" or the "Company"), an innovative biotech company developing new disease modifying therapies for Parkinson’s disease, reported on 30 March 2022 the result of the offering of new shares (the "Placing Shares") in a directed share issue to institutional and other qualified investors (the "Directed Issue") (Press release, Herantis Pharma, APR 4, 2022, View Source;975-000-new-shares-registered-with-the-trade-register,c3539149 [SID1234611398]). In the Directed Issue, the Company issued a total of 975,000 Placing Shares. The Placing Shares have today been registered with the trade register maintained by the Finnish Patent and Registration Office.

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Following the registration of the Placing Shares, the total number of registered shares in the Company is 12,078,568. The Placing Shares will be issued in the book-entry system (ISIN code FI4000087861) on or about 5 April 2022. After this, and registration on the investors’ book-entry accounts, the Placing Shares will confer shareholder rights in the Company. The Placing Shares are expected to be ready for delivery to the investors through Euroclear Finland Oy or, as applicable, through Euroclear Sweden AB on or about 5 April 2022.

Trading in the Placing Shares is expected to commence on Nasdaq First North Growth Market Finland and Nasdaq First North Growth Market Sweden on or about 6 April 2022.

On April 4, 2022 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that it expected to file its Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (the "Annual Report") in the near term (Press release, Supernus, APR 4, 2022, View Source [SID1234611396]).

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Full Year 2022 Financial Guidance (GAAP)

(1) Includes net product sales and royalty revenue.
(2) Includes amortization of intangible assets and contingent consideration expense (gain).

Full Year 2022 Financial Guidance — GAAP to Non-GAAP Adjustments

Non-GAAP Financial Information
The Company’s 2022 financial guidance in this press release contains a financial measure, non-GAAP operating earnings, which does not comply with United States generally accepted accounting principles (GAAP). The non-GAAP financial measure should be considered in addition to, not as a substitute for or in isolation from, or superior to measures prepared in accordance with GAAP. Non-GAAP operating earnings adjusts for non-cash share-based compensation expense, depreciation and amortization, and accretion of contingent consideration, and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables in this press release. We believe the use of non-GAAP operating earnings measure is useful supplemental information to investors regarding the Company’s results of operations and assists management, analysts, and investors in evaluating the performance of the business. There are limitations associated with the use of non-GAAP financial measure. Including such measure may not be entirely comparable to similarly titled measures used by other companies, may not reflect all items of income and expense, as applicable, that affect our operations, potential differences among calculation methodologies, may differ from the non-GAAP information used by other companies, including peer companies, and therefore comparability may be limited. We mitigate these limitations by reconciling the non-GAAP financial measures to the most comparable GAAP financial measures. Investors are encouraged to review the reconciliation.

On April 4, 2022 Nirogy Therapeutics Inc., a privately-held biotechnology company developing novel small molecules to target cellular transporters, reported that the company will present two posters at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, to be held during April 8-13, 2022 (Press release, Nirogy Therapeutics, APR 4, 2022, View Source [SID1234611395]).

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Nirogy will highlight preliminary data that shows NGY-B, the company’s first-in-class, orally bioavailable small molecule lactate transport inhibitor, intervenes in multiple pathways of metabolism while locally activates anti-tumor immunity in the tumor microenvironment (TME), providing a novel therapeutic modality to combat broader tumor types.

"We’re excited to present two impactful posters which highlight our multi-pronged approach to address significant unmet medical need for hard-to-treat tumors at this year’s AACR (Free AACR Whitepaper) conference" said Vincent Sandanayaka, Ph.D., founder, president, and chief scientific officer of Nirogy. "These preliminary data show that NGY-B has significant efficacy in ‘immunologically cold’ syngeneic and patient-derived xenograft mouse models in triple negative breast cancer, ovarian and renal cell carcinoma where currently no effective therapies are available. We have also observed further enhancement of efficacy of this compound by combining with immune checkpoint blockade such as anti-PD-1 and anti-CTLA4 inhibitors, suggesting a potential future combination therapy to address resistance mechanisms developed by checkpoint inhibitors. We look forward to sharing additional data as we move the development candidate to the clinic in the coming months."

Poster Presentation Details
Title: Efficacy of a Small Molecule Inhibitor of MCT1 and MCT4 Transporters in Cancer
Presenters: Sambad Sharma, Gregory J Goreczny, Nicole Bowman, Jennifer Duffy, Daliya Banergee, Kerui Wu, Abhishek Tyagi, Shih-Ying Wu, Kounosuke Watabe, John Dzuris, Jaime Escobedo, Vincent Sandanayaka
Session: Novel Targets and Pathways
Poster Section: 24
Presentation Number: 5719
Date and Time: Tuesday, April 12, 2022, 9:00 a.m. – 12:30 p.m. CST

Title: NGY-B is a Novel Inhibitor of MCT Transporters Blocking Lactate and Glucose Metabolisms
Presenters: Sambad Sharma, Gregory J Goreczny, Nicole Bowman, Jennifer Duffy, Daliya Banerjee, Sanath Wijerathna, John Dzuris, Jaime Escobedo, Vincent Sandanayaka
Session: New Chemotherapy Agents
Poster Section: 27
Presentation Number: 5632
Date and Time: Wednesday, April 13, 2022, 9:00 a.m. – 12:30 p.m. CST

On April 4, 2022 Castle Biosciences, Inc., a Delaware corporation (the "Company"), Acorn Merger Sub, Inc., a Delaware corporation ("Merger Sub"), AltheaDx, Inc., a Delaware corporation ("AltheaDx"), and Fortis Advisors LLC, a Delaware limited liability company, in its capacity as the securityholders’ agent (the "Securityholders’ Agent"), entered into an Agreement and Plan of Merger (the "Merger Agreement"), reported to which the Company agreed to acquire AltheaDx (Press release, Castle Biosciences, APR 4, 2022, View Source [SID1234611394]).

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Pursuant to the terms and conditions of the Merger Agreement, Merger Sub will merge with and into AltheaDx (the "Merger") whereupon the separate corporate existence of Merger Sub will cease, with AltheaDx continuing as the surviving corporation and a wholly owned subsidiary of the Company.

AltheaDx is a commercial-stage molecular diagnostics company specializing in the field of pharmacogenomics testing services that are focused on mental health. AltheaDx currently offers the IDgenetix test for depression, anxiety and other mental health conditions. In 2021, AltheaDx generated revenues of less than $1.0 million.

Pursuant to the Merger Agreement and upon the consummation of the potential Merger, the Company will pay to AltheaDx securityholders, in accordance with AltheaDx’s organizational documents, upfront consideration of $32.5 million in cash, subject to a customary adjustment for cash, debt, working capital and transaction expenses, and $32.5 million in shares of the Company’s common stock. A portion of the upfront cash consideration will be held in escrow for a specified period following the closing of the Merger to secure post-closing purchase price adjustments, and a portion of the upfront cash consideration will be deposited with the Securityholders’ Agent to be used for the satisfaction of any losses and expenses of the Securityholders’ Agent in connection with the Merger Agreement or the ancillary agreements entered into by the Securityholders’ Agent. In addition, a portion of the upfront cash and stock consideration will be held in escrow for a specified period following the closing of the Merger to secure indemnification claims of the Company, if any. The number of shares issuable at the closing of the Merger will be based on a price per share equal to the volume-weighted-average price of the Company’s common stock for the 20 trading days immediately preceding the date of the Merger Agreement. The upfront cash portion of the Merger consideration is subject to a customary post-closing purchase price adjustment mechanism for, among other things, cash, unpaid indebtedness, unpaid transaction expenses and working capital. Under the Merger Agreement, the Company has also agreed to pay up to an additional $75.0 million of milestone payments based on the achievement of certain net revenue targets relating to the fiscal years ending December 31, 2022, 2023 and 2024 and certain expansions of Medicare coverage for IDgenetix relating to coverage of, and proof of reimbursement for, certain additional indications by a specified date. Upon achievement of the relevant milestone events, each milestone payment will be paid 50% in cash and 50% in the Company’s common stock, with such common stock valued at the volume-weighted-average price of the Company’s common stock for the 20 trading days as of the applicable determination date, provided that the number of shares of the Company’s common stock issuable to AltheaDx securityholders in connection with the Merger may not exceed 4.99% of the number of outstanding shares of the Company’s common stock as of the date of the Merger Agreement. In the event a number of shares in excess of the 4.99% limit would otherwise be issuable as consideration in the Merger, each AltheaDx securityholder will receive a pro rata reduction of their portion of the milestone stock consideration and a corresponding increase in their portion of the milestone cash consideration.

The closing of the Merger is expected to occur in the second quarter of 2022 and is subject to (i) delivery of certain financial statements to the Company by AltheaDx, (ii) the continued employment of certain AltheaDx employees, (iii) the delivery of certain ancillary agreements, (iv) the requisite AltheaDx stockholder approval having been obtained, (v) no more than a certain percentage of AltheaDx stockholders having perfected or being entitled to appraisal rights, (vi) a certain percentage of AltheaDx securityholders having executed joinder agreements, accredited investor questionnaires and lock-up agreements, (vii) no order, legal regulatory restraint or law preventing the consummation of the Merger being in effect, (viii) the representations and warranties of AltheaDx and Castle contained in the Merger Agreement being true and correct, subject to certain materiality standards, (ix) AltheaDx and Castle having performed and complied in all material respects with their covenants, agreements and obligations, (x) there having not occurred a material adverse effect with respect to AltheaDx and (xi) the satisfaction of other customary conditions. Among other termination provisions, AltheaDx and the Company each have the right to terminate the Merger Agreement, subject to certain conditions and limitations, if the closing of the Merger has not occurred prior to June 30, 2022.

The Merger Agreement contains customary representations and warranties of the Company, Merger Sub and AltheaDx as well as customary covenants and additional agreements. The Merger Agreement includes indemnification provisions whereby the securityholders of AltheaDx will indemnify the Company for losses arising out of, among other things, inaccuracies in, or breaches of, the representations, warranties and covenants of AltheaDx, claims for appraisal rights by holders of AltheaDx capital stock, pre-closing taxes of AltheaDx, claims by current or former securityholders of AltheaDx relating to the Merger Agreement or their status as a securityholder, inaccuracies in or omissions from the calculations of consideration payable to each securityholder and any undischarged debt of AltheaDx or unpaid transaction expenses of AltheaDx, subject to certain caps and other limitations. To support such indemnification obligations, the Company will have recourse to certain escrowed cash and shares and, in certain limited cases, by setting off such obligations against any milestone payments and/or directly against the AltheaDx securityholders.

The shares of common stock of the Company that may be issued as consideration for the Merger are not being registered under the Securities Act of 1933, as amended (the "Securities Act"), and are being offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506 of Regulation D thereunder. The Company has agreed to file a resale registration statement covering the shares of the Company’s common stock issuable under the Merger Agreement within 40 days of the closing of the Merger, subject to the receipt of certain information from AltheaDx and its securityholders and certain specified exceptions.

The Company’s entry into the Merger Agreement was approved by the Company’s Board of Directors based upon the unanimous recommendation of a special transaction committee comprised solely of independent and disinterested directors. Derek J. Maetzold, the Company’s President and Chief Executive Officer, and a member of the Company’s Board of Directors, and Daniel M. Bradbury, the Chairman of the Company’s Board of Directors, each serve on the board of directors of AltheaDx. Further, each of the following individuals is a direct or indirect beneficial owner of AltheaDx securities and will receive consideration in the Merger: Mr. Bradbury; Mr. Maetzold; Thomas Sullivan, John Maetzold and Peter Maetzold, immediate family members of Mr. Maetzold; Frank Stokes, the Company’s Chief Financial Officer; Tobin Juvenal, the Company’s Chief Commercial Officer; Kristen Oelschlager, the Company’s Chief Operating Officer; and Joshua Albers and Allysa Topel, immediate family members of Ms. Oelschlager.

On April 4, 2022 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune and infectious diseases reported that the European Commission (EC) has approved KIMMTRAK (tebentafusp) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM) (Press release, Immunocore, APR 4, 2022, View Source [SID1234611393]). KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function.

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"The approval of KIMMTRAK by the European Commission is a historic step as the first ever TCR therapy to be approved in the E.U.," said Bahija Jallal, Chief Executive Officer of Immunocore. "KIMMTRAK, a bispecific T-cell engager, is the first therapy to demonstrate a survival benefit in patients with unresectable or metastatic uveal melanoma. We are excited about what today’s approval means for patients and their caregivers and we are working closely with national health authorities to make KIMMTRAK available as quickly as possible."

The EC approval follows a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) in February 2022. The CHMP recommendation of KIMMTRAK is based on the results of Immunocore’s Phase 3 IMCgp100-202 clinical trial, which were published in the September 23, 2021 issue of the New England Journal of Medicine.

Data from the trial, the largest Phase 3 trial undertaken in mUM, showed that KIMMTRAK demonstrated unprecedented median OS benefit as a first-line treatment. The OS Hazard Ratio (HR) in the intent-to-treat population favoured KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice of treatment (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine). In this study IMCgp100-202, 43% of patients received treatment beyond progression with tebentafusp with no new safety signals identified. Median duration of tebentafusp treatment beyond progression was 8 weeks. Of the total tebentafusp infusions during the study, 21.5% was administered after progression.

"For years, metastatic uveal melanoma patients have had no treatment choice that is active – today’s approval offers them new hope and a chance at longer survival," commented Dr. Sophie Piperno-Neumann, Medical Oncologist at the Institute Curie. "As a treating physician, it is heart-warming to finally be able to offer a licensed medicine to eligible patients. KIMMTRAK represents a paradigm shift in the treatment of unresectable or metastatic uveal melanoma."

In the randomised Phase 3 trial of KIMMTRAK (tebentafusp), treatment-related adverse reactions were generally manageable and consistent with the proposed mechanism of action. Among the patients treated with KIMMTRAK, the most common Grade 3 or higher adverse events were rash (18%), pyrexia (4%), and pruritus (5%). In the 245 patients treated with KIMMTRAK, Grade 3 cytokine release syndrome (CRS) occurred in <1% of patients and were generally well-managed. There were no Grade 4 or higher CRS events observed in the Phase 3 clinical trial.

Dr. Jessica Hassel, Head of Dermatooncology at Heidelberg University Hospital, said "The approval of tebentafusp by the EMA is a great step forward in the treatment of metastatic uveal melanoma. Being the first agent with a proven survival benefit, this approval provides hope to patients with uveal melanoma. And for us treating physicians, it is a significant advancement to be able to offer these patients an effective treatment with good tolerability."

With EC approval, KIMMTRAK has received marketing authorisation in all E.U. member states, and following completion of related national procedures, also in Iceland, Liechtenstein, and Norway. The United Kingdom’s Medicines and Healthcare Regulatory Agency (MHRA), Health Canada, and the Australian Government Department of Health Therapeutic Goods Administration (TGA) have each accepted the submission of the Company’s Marketing Authorisation Application.

In January 2022, the United States Food and Drug Administration (FDA) approved KIMMTRAK (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

About Uveal Melanoma

Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, and up to 50% of people with uveal melanoma will eventually develop metastatic disease. Unresectable or metastatic uveal melanoma typically has a poor prognosis and had no approved treatment until KIMMTRAK.

About KIMMTRAK

KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. KIMMTRAK has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA in the United States, Accelerated Assessment by the EMA, and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma.

About Phase 3 IMCgp100-202 Trial

The IMCgp100-202 (NCT03070392) is a randomized pivotal trial that evaluated overall survival (OS) of KIMMTRAK (tebentafusp-tebn) compared to investigator’s choice (either pembrolizumab, ipilimumab, or dacarbazine) in HLA-A*02:01-positive adult patients with previously untreated mUM. KIMMTRAK demonstrated an unprecedented OS benefit with a Hazard Ratio (HR) in the intent-to-treat population favoring KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine).

IMPORTANT U.S. SAFETY INFORMATION Regarding FDA Approval

Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated. Manifestations of CRS may include fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache. CRS occurred in 89% of patients who received KIMMTRAK with 0.8% being grade 3 or 4. Ensure immediate access to medications and resuscitative equipment to manage CRS. Ensure patients are euvolemic prior to initiating the infusions. Closely monitor patients for signs or symptoms of CRS following infusions of KIMMTRAK. Monitor fluid status, vital signs, and oxygenation level and provide appropriate therapy. Withhold or discontinue KIMMTRAK depending on persistence and severity of CRS.

Skin Reactions

Skin reactions, including rash, pruritus, and cutaneous edema occurred in 91% of patients treated with KIMMTRAK. Monitor patients for skin reactions. If skin reactions occur, treat with antihistamine and topical or systemic steroids based on persistence and severity of symptoms. Withhold or permanently discontinue KIMMTRAK depending on the severity of skin reactions.

Elevated Liver Enzymes

Elevations in liver enzymes occurred in 65% of patients treated with KIMMTRAK. Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total blood bilirubin prior to the start of and during treatment with KIMMTRAK. Withhold KIMMTRAK according to severity.

Embryo-Fetal Toxicity

KIMMTRAK may cause fetal harm. Advise pregnant patients of potential risk to the fetus and patients of reproductive potential to use effective contraception during treatment with KIMMTRAK and 1 week after the last dose.

The most common adverse reactions (≥30%) in patients who received KIMMTRAK were cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting. The most common (≥50%) laboratory abnormalities were decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate.

About ImmTAC Molecules

Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognise and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognise intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumours, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumours, regardless of mutational burden or immune infiltration, including immune "cold" low mutation rate tumours.