On August 12, 2020 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that Australian regulatory authorities have approved TUKYSA (tucatinib) in combination with trastuzumab and capecitabine for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting (Press release, Seattle Genetics, AUG 12, 2020, View Source [SID1234563527]). Australia joins U.S., Switzerland, Canada and Singapore that approved TUKYSA under Project Orbis, an initiative of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among participating international regulatory agencies.

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In April, TUKYSA became the first new medicine approved in the United States under Project Orbis, and its approval is currently under review in the European Union. TUKYSA is an oral, small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein that contributes to cancer cell growth.1,2

"The rapid approval of concurrent global reviews under FDA’s Project Orbis for TUKYSA will allow for accelerated market entry of this new best-in-class treatment to HER2-positive breast cancer patients in need," said Clay Siegall, Ph.D., Chief Executive Officer at Seattle Genetics. "As our company continues to expand globally, we look forward to bringing TUKYSA to patients around the world."

The approvals are based on results from the pivotal trial HER2CLIMB, a randomized (2:1), double-blind, placebo-controlled trial that enrolled 612 patients with HER2-positive unresectable locally advanced or metastatic breast cancer who had previously received, either separately or in combination, trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1). The study results were published inThe New England Journal of Medicinein December 2019. The company is pursuing a broad development strategy for TUKYSA in earlier stage HER2-positive breast cancer and other solid tumors.

About HER2-Positive Breast Cancer

Patients with HER2-positive breast cancer have tumors with high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. In 2018, more than two million new cases of breast cancer were diagnosed worldwide, including nearly 523,000 in Europe.3 Between 15 and 20 percent of breast cancer cases are HER2-positive.4 Historically, HER2-positive breast cancer tends to be more aggressive and more likely to recur than HER2-negative breast cancer.5,6,7 Up to 50 percent of metastatic HER2-positive breast cancer patients develop brain metastases over time.8,9,10

About TUKYSA (tucatinib)

TUKYSA is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. In vitro (in lab studies), TUKYSA inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell growth (proliferation), and showed anti-tumor activity in HER2-expressing tumor cells. In vivo (in living organisms), TUKYSA inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.11 In the U.S., TUKYSA is approved in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases (disease that has spread to the brain), who have received one or more prior anti-HER2-based regimens in the metastatic setting.

TUKYSA is approved in the U.S., Switzerland, Canada, Singapore and Australia and is under review for approval in the EU.

U.S. Important Safety Information

Warnings and Precautions

Diarrhea – TUKYSA can cause severe diarrhea including dehydration, hypotension, acute kidney injury, and death. In HER2CLIMB, 81% of patients who received TUKYSA experienced diarrhea, including 12% with Grade 3 diarrhea and 0.5% with Grade 4 diarrhea. Both patients who developed Grade 4 diarrhea subsequently died, with diarrhea as a contributor to death. The median time to onset of the first episode of diarrhea was 12 days and the median time to resolution was 8 days. Diarrhea led to dose reductions of TUKYSA in 6% of patients and discontinuation of TUKYSA in 1% of patients. Prophylactic use of antidiarrheal treatment was not required on HER2CLIMB.
If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Based on the severity of the diarrhea, interrupt dose, then dose reduce or permanently discontinue TUKYSA

Hepatotoxicity – TUKYSA can cause severe hepatotoxicity. In HER2CLIMB, 8% of patients who received TUKYSA had an ALT increase >5 × ULN, 6% had an AST increase >5 × ULN, and 1.5% had a bilirubin increase >3 × ULN (Grade ≥3). Hepatotoxicity led to dose reduction of TUKYSA in 8% of patients and discontinuation of TUKYSA in 1.5% of patients.
Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA.

Embryo-Fetal Toxicity – TUKYSA can cause fetal harm. Advise pregnant women and females of reproductive potential risk to a fetus. Advise females of reproductive potential, and male patients with female partners of reproductive potential, to use effective contraception during TUKYSA treatment and for at least 1 week after the last dose.
Adverse Reactions

Serious adverse reactions occurred in 26% of patients who received TUKYSA. Serious adverse reactions in ≥2% of patients who received TUKYSA were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock.

Adverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; those occurring in ≥1% of patients were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions led to dose reduction in 21% of patients who received TUKYSA; those occurring in ≥2% of patients were hepatotoxicity (8%) and diarrhea (6%).

The most common adverse reactions in patients who received TUKYSA (≥20%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.

Lab Abnormalities

In HER2CLIMB, Grade ≥3 laboratory abnormalities reported in ≥5% of patients who received TUKYSA were: decreased phosphate, increased ALT, decreased potassium, and increased AST. The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.

Drug Interactions

Strong CYP3A or Moderate CYP2C8 Inducers: Concomitant use may decrease TUKYSA activity. Avoid concomitant use of TUKYSA.
Strong or Moderate CYP2C8 Inhibitors: Concomitant use of TUKYSA with a strong CYP2C8 inhibitor may increase the risk of TUKYSA toxicity; avoid concomitant use. Increase monitoring for TUKYSA toxicity with moderate CYP2C8 inhibitors.
CYP3A Substrates: Concomitant use may increase the toxicity associated with a CYP3A substrate. Avoid concomitant use of TUKYSA where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, decrease the CYP3A substrate dosage.
P-gp Substrates: Concomitant use may increase the toxicity associated with a P-gp substrate. Consider reducing the dosage of P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicity.
Use in Specific Populations

Lactation: Advise women not to breastfeed while taking TUKYSA and for at least 1 week after the last dose.
Renal Impairment: Use of TUKYSA in combination with capecitabine and trastuzumab is not recommended in patients with severe renal impairment (CLcr < 30 mL/min), because capecitabine is contraindicated in patients with severe renal impairment.
Hepatic Impairment: Reduce the dose of TUKYSA for patients with severe (Child-Pugh C) hepatic impairment.

On August 12, 2020 Trillium Therapeutics Inc. ("Trillium" or the "Company") (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported financial and operating results for the six months ended June 30, 2020 (Press release, Trillium Therapeutics, AUG 12, 2020, View Source [SID1234563526]).

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"We had a strong quarter, further advancing dose escalation of our lead candidates TTI-621 and TTI-622. After an initial slow-down in TTI-621 patient enrollment due to Covid-19, we successfully completed safety assessment of the 1.4 mg/kg cohort at the end of July, and moved up to 2.0 mg/kg dosing", said Jan Skvarka, Trillium’s President and Chief Executive Officer. "In May, we provided a data update for TTI-622 at ASCO (Free ASCO Whitepaper). We are very encouraged by the molecule’s emerging clinical profile, which combines strong safety with early evidence of monotherapy activity. For both molecules the next updates are planned for the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2020."

TTI-622 Study Update at ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program:

On May 29, 2020, Trillium presented updated clinical data on 19 relapsed/refractory lymphoma patients in the first 5 cohorts of the TTI-622 study at the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program annual meeting. These data highlight strong tolerability, with both drug exposure and target engagement showing dose response relationships. Objective responses, including one complete response, were observed in two heavily pretreated diffuse large B-cell lymphoma patients.

Second Quarter 2020 Financial Results:

As of June 30, 2020, Trillium had cash and cash equivalents and marketable securities of $130.8 million, compared to $22.7 million at December 31, 2019. The increase in cash and cash equivalents and marketable securities was due mainly to proceeds from an underwritten public offering completed in January 2020.

Net loss for the six months ended June 30, 2020 of $122.5 million was higher than the loss of $12.9 million for the six months ended June 30, 2019. The net loss was higher due mainly to a net warrant liability revaluation loss of $88.0 million, a loss of $22.1 million on the revaluation of the deferred share unit (DSU) liability (reclassified from a liability to equity effective June 30, 2020 on adoption of the new omnibus incentive plan), and higher manufacturing costs. This was partially offset by lower clinical trial, intangible assets amortization, share-based compensation, and salary expenses, as well as a net foreign currency gain.

Trillium’s outstanding warrants are a non-cash liability, and revaluation losses on the Company’s warrant liability balance are of a non-cash nature. On June 30, 2020, shareholders approved the 2020 Omnibus Equity Incentive Plan at the Annual General and Special Meeting of Shareholders. As Trillium intends to settle all outstanding DSUs issued for director compensation in equity, accordingly all previously existing cash-settled DSUs accounted for as a liability was reclassified to equity as of June 30, 2020.

On August 12, 2020 Omeros Corporation (Nasdaq: OMER) ("Omeros") reported that it has priced concurrent underwritten public offerings of 6,900,000 of shares of its common stock (the "Shares") at a public offering price of $14.50 per Share for proceeds of approximately $100,050,000, prior to the deduction of underwriting discounts and commissions and estimated offering expenses payable by Omeros (the "Equity Offering"), and $210,000,000 aggregate principal amount of 5.25% convertible senior notes due 2026 (the "2026 Convertible Notes" and such offering, the "Notes Offering") (Press release, Omeros, AUG 12, 2020, View Source [SID1234563525]). In addition, Omeros has granted to the underwriters of the Equity Offering a 30-day option to purchase up to an additional 1,035,000 Shares and to the underwriters of the Notes Offering a 30-day option, solely to cover over-allotments, to purchase up to an additional $31,500,000 aggregate principal amount of 2026 Convertible Notes. The Equity Offering and the Notes Offering are each expected to close on August 14, 2020, subject to customary closing conditions. Neither offering is contingent on the completion of the other offering.

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BofA Securities and JP Morgan are acting as the book-running managers for the Equity Offering. Cantor Fitzgerald is also acting as a book-running manager, and WBB Securities is acting as co-manager, for the Equity Offering. BofA Securities, JP Morgan and RBC Capital Markets are acting as the book-running managers for the Notes Offering.

The 2026 Convertible Notes will be senior unsecured obligations of Omeros and will bear interest at a rate of 5.25% per year, payable semi-annually in arrears. The 2026 Convertible Notes will mature on February 15, 2026, unless earlier converted, repurchased or redeemed in accordance with their terms, and will be convertible, subject to the satisfaction of certain conditions, into cash, shares of Omeros’ common stock or a combination thereof as elected by Omeros in its sole discretion.

The initial conversion rate for the 2026 Convertible Notes is 54.0906 shares of Omeros’ common stock per $1,000 principal amount of 2026 Convertible Notes (which is equivalent to an initial conversion price of approximately $18.49 per share, which represents a premium of approximately 27.5% over the public offering price of Omeros’ common stock in the Equity Offering of $14.50 per share). Omeros will have the right to redeem the 2026 Convertible Notes on or after August 15, 2023, subject to certain conditions and limitations.

The Equity Offering is expected to result in approximately $93.7 million in net proceeds to Omeros, and the Notes Offering is expected to result in approximately $203.7 million in net proceeds to Omeros, in each case, after deducting underwriting discounts and commissions and estimated offering expenses payable by Omeros, and in each case, assuming no exercise of the underwriters’ option to purchase additional Shares or 2026 Convertible Notes.

Omeros intends to use approximately $21.7 million of the net proceeds of the Notes Offering to fund the cost of entering into capped call transactions with the option counterparties, as described below. In addition, Omeros intends to use approximately $127.4 million of the net proceeds of the Notes Offering to repurchase approximately $115 million aggregate principal amount of its existing 6.25% Convertible Senior Notes due 2023 (the "2023 Convertible Notes") in privately negotiated transactions as described below, and expects to receive approximately $8.4 million from unwinding a proportionate amount of the capped call transaction that it entered into with a financial institution (the "existing option counterparty") in connection with the issuance of the 2023 Convertible Notes (the "existing capped call transaction").

Omeros intends to use the net proceeds from the Equity Offering and the remainder of the net proceeds from the Notes Offering for general corporate purposes, including funding clinical trials, pre-clinical studies, manufacturing, build-out of commercial infrastructure and other costs associated with advancing its development programs and product candidates toward regulatory submissions and potential commercialization.

In connection with the pricing of the 2026 Convertible Notes, Omeros entered into privately negotiated capped call transactions with certain financial institutions ("option counterparties"). The capped call transactions are intended to reduce the potential dilution with respect to Omeros’ common stock or, at its election (subject to certain conditions), offset potential cash payments in excess of the principal amount of the converted 2026 Convertible Notes, upon conversion of the 2026 Convertible Notes, with such reduction or offset subject to a cap of $26.10, representing a premium of 80% over the public offering price of Omeros’ common stock in the Equity Offering. If the underwriters exercise their option to purchase additional 2026 Convertible Notes, Omeros expects to enter into additional capped call transactions with the option counterparties.

Omeros has been informed that in connection with establishing their initial hedges of the capped call transactions, the option counterparties and/or their affiliates expect to purchase shares of Omeros’ common stock and/or enter into various derivative transactions with respect to Omeros’ common stock concurrently with or shortly after the pricing of the 2026 Convertible Notes. This activity could increase (or reduce the size of any decrease in) the market price of Omeros’ common stock or the 2026 Convertible Notes at that time.

In addition, the option counterparties and/or their affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Omeros’ common stock and/or purchasing or selling Omeros’ common stock or other securities of Omeros’ in secondary market transactions prior to the maturity of the 2026 Convertible Notes (and are likely to do so on each exercise date of the capped call transactions, which are expected to occur during the 50-trading day period beginning on the 51st scheduled trading day prior to the maturity date of the notes, or following any termination of any portion of the capped call transactions in connection with any repurchase, redemption or conversion of the 2026 Convertible Notes if Omeros makes the relevant election under the capped call transactions). This activity could also cause or avoid an increase or a decrease in the market price of Omeros’ common stock or the 2026 Convertible Notes, which could affect a noteholder’s ability to convert the 2026 Convertible Notes and, to the extent the activity occurs during any observation period related to a conversion of the 2026 Convertible Notes, could affect the amount and value of the consideration that a noteholder will receive upon conversion of the 2026 Convertible Notes.

Concurrently with the Notes Offering, Omeros intends to use approximately $127.4 million of the proceeds from the offering to repurchase approximately $115 million aggregate principal amount of its outstanding 2023 Convertible Notes in privately negotiated transactions. Omeros expects that holders of the 2023 Convertible Notes that sell their 2023 Convertible Notes to Omeros in any note repurchase transaction may enter into or unwind various derivatives with respect to Omeros’ common stock and/or purchase or sell shares of Omeros’ common stock in the market to hedge their exposure in connection with these transactions. This activity could increase (or reduce the size of any decrease in) the market price of Omeros’ common stock or the 2026 Convertible Notes at that time and could result in a higher effective conversion price for the 2026 Convertible Notes.

In connection with the repurchase of the 2023 Convertible Notes, Omeros intends to terminate a portion of the existing capped call transaction in a notional amount corresponding to the amount of such 2023 Convertible Notes repurchased. In connection with the partial termination of the existing capped call transaction and the related unwinding of the existing hedge position of the existing option counterparty with respect to such transaction, the existing option counterparty and/or its respective affiliates are expected to sell shares of Omeros’ common stock in secondary market transactions, and/or enter into or unwind various derivative transactions with respect to Omeros’ common stock. This activity could decrease (or reduce the size of any increase in) the market price of Omeros’ common stock or the 2026 Convertible Notes at that time.

The Equity Offering and the Notes Offering are being made pursuant to Omeros’ shelf registration statement on Form S-3 (File No. 333-235349) including the base prospectus contained therein, and a prospectus supplement related to the Equity Offering (together with such base prospectus, the "Equity Prospectus") and a prospectus supplement related to the Notes Offering (together with such base prospectus, the "Notes Prospectus"), all of which Omeros filed or will file with the Securities and Exchange Commission ("SEC"). Before investing in the Shares or the 2026 Convertible Notes, investors should read the Equity Prospectus and the Notes Prospectus, respectively, in each case, including the documents incorporated by reference therein, and any free writing prospectus related to the Equity Offering and the Notes Offering, as the case may be. These documents may be freely obtained by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies may be obtained, when available, from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or via email: [email protected] and J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by e-mail at [email protected].

On August 12, 2020 Verrica Pharmaceuticals Inc. ("Verrica") (NASDAQ: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, reported that the Company has entered into an exclusive worldwide license agreement with Lytix Biopharma AS ("Lytix") to develop and commercialize LTX-315 for dermatologic oncology indications (Press release, Verrica Pharmaceuticals, AUG 12, 2020, View Source [SID1234563524]). Verrica intends to focus initially on basal cell and squamous cell carcinomas as the lead indications for development. LTX-315 is a first-in-class oncolytic peptide that is injected directly into a tumor to induce immunogenic cell death. The compound has demonstrated positive tumor-specific immune cell responses in multi-indication Phase I/II oncology trials.

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"This is an important milestone in the broadening of Verrica’s strategy to bring breakthrough treatments for skin diseases to patients and physicians, as dermatologic cancers are highly prevalent and many patients suffer from them," said Dr. Gary Goldenberg, Verrica’s Chief Medical Officer. "Innovation in dermatology is one of the primary drivers that prompted me to recently join Verrica, and LTX-315’s unique mechanism of action is clearly an innovative approach to potentially provide significant improvement over invasive surgery. LTX-315 has the potential to revolutionize one of the most common disease states in dermatology – non-melanoma skin cancers. We look forward to leveraging Verrica’s depth of clinical development experience to develop this innovative asset for the potential benefit of patients. We intend to submit an IND in the United States for LTX-315 during the first half of 2021 and commence clinical development thereafter."

"Skin cancer is the most common cancer in the U.S., with 5 million diagnoses of basal and squamous cell carcinomas each year,"1 said Darrell Rigel, MD, Clinical Professor of Dermatology at NYU. "Patients are typically treated with surgery, which can result in damage to healthy tissue, pain, and permanent scarring. LTX-315 is a clinical-stage, non-surgical immunotherapy product candidate that directly targets cancerous skin cells, with the potential to transform the treatment of skin cancer by offering a therapeutic alternative to surgery."

"We are pleased to enter into this collaboration with Verrica, which has significant expertise within the field of dermatology," said Øystein Rekdal, Lytix`s CEO. "Our lead drug candidate, LTX-315, has shown very promising efficacy and safety signals in cancer patients during Phase I/II studies and we are excited that this partnership with Verrica will expand the applications for LTX-315."

Under the terms of the agreement, Lytix will be entitled to receive an upfront payment, contingent regulatory milestones based on achievement of specified development goals, and sales milestones, with aggregate payments of up to $113.5 million, in addition to tiered royalties based on worldwide annual sales. The agreed upon royalty rates start in the low double digits and increase to the mid-teens based on net sales achieved.

Verrica is solely responsible for the development, regulatory filings, and commercialization of LTX-315 in dermatology, while Lytix is responsible for manufacturing the active pharmaceutical ingredient. The license includes worldwide rights for Verrica to develop and commercialize LTX-315 for all malignant and pre-malignant dermatological indications, except for metastatic melanoma and metastatic Merkel cell carcinoma.

The Company reaffirms its belief that its existing cash, cash equivalents, and marketable securities will be sufficient to support planned operations, inclusive of this agreement with Lytix and LTX-315 development activities, at least through the fourth quarter of 2021.

On August 12, 2020 Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, reported a conference call and webcast presentation regarding its recent directed share issue generating gross proceeds of USD 65 million (approximately SEK 567 million) (Press release, Saniona, AUG 12, 2020, View Source [SID1234563523]).

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The event will take place on Friday August 14th at 2 p.m. CET and will feature a presentation by Saniona’s management team to discuss the strategy and rationale for the financing, as well as an update on Saniona’s advancement of its late-stage clinical trials with Tesomet in two rare eating disorders, hypothalamic obesity (HO) and Prader Willi Syndrome (PWS), as well as progress building its U.S.-based organization in support of these programs.

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Event number: 137 140 9570

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Event number: 137 140 9570

For those who are unable to listen at this time, a replay of the call will be available after the event through the investor section of Saniona’s web site at View Source