On January 26, 2022 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported financial results for the third quarter of fiscal year 2021 and other corporate updates (Press release, Myovant Sciences, JAN 26, 2022, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-announces-financial-results-third-quarter [SID1234607408]).

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"Our third fiscal quarter 2021 financial results reflect the continued strong momentum for the ORGOVYX and MYFEMBREE launches. ORGOVYX volume grew 40% sequentially, reflecting steadily increasing patient and clinician demand for its differentiated clinical profile compared to other androgen deprivation therapy alternatives. By December 2021, MYFEMBREE had captured 45% new-to-brand prescription share among GnRH antagonist therapies FDA-approved for the treatment of uterine fibroids, significant progress only six months following launch. This notable performance for both brands reaffirms our belief that ORGOVYX and MYFEMBREE have the potential to become standard of care therapies in advanced prostate cancer and uterine fibroids, respectively, and represent significant commercial opportunities over time," said David Marek, Chief Executive Officer of Myovant Sciences, Inc.

Mr. Marek added, "We anticipate 2022 will be a significant growth year with several important milestones that will support our mission of redefining care and position Myovant for long-term success. In addition to executing commercially, we look forward to submitting for FDA review the results of the LIBERTY randomized withdrawal study in women with uterine fibroids, completing the two-year SPIRIT long-term extension study of MYFEMBREE in women with endometriosis-associated pain, and potentially launching MYFEMBREE in endometriosis in the U.S. pending FDA approval, while also expanding our pipeline by advancing relugolix lifecycle opportunities and pursuing business development."

Third Fiscal Quarter 2021 and Recent Corporate Updates

ORGOVYX (relugolix 120 mg)

Third fiscal quarter 2021 net product revenues for ORGOVYX in the U.S. were $24.4 million, reflecting 40% sequential volume growth compared to second fiscal quarter 2021, partially offset by a lower net price due to higher gross-to-net discounts. There were no material changes in inventory for ORGOVYX over the course of third fiscal quarter 2021.
Over 1,800 treatment centers prescribed ORGOVYX to approximately 11,000 patients on free and commercial drug, from launch through December 2021, excluding patients utilizing product samples. The cumulative number of estimated patients initiating ORGOVYX therapy has continued to increase steadily in each successive month since launch.
As of January 2022, Myovant achieved 81% commercial coverage and 99% Medicare Part D coverage for ORGOVYX. Myovant continues to engage with key commercial and Part D payers to maintain coverage as well as to potentially expand coverage with payers yet to make a coverage decision.
MYFEMBREE (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg)

Third fiscal quarter 2021 net product revenues for MYFEMBREE in the U.S. were $2.4 million. There were no material changes in inventory for MYFEMBREE over the course of third fiscal quarter 2021.
New-to-brand prescription share among gonadotropin-releasing hormone (GnRH) antagonists approved by the U.S. Food and Drug Administration (FDA) for the treatment of uterine fibroids was 45% in December 2021 compared to 20% in September 2021, reflecting steadily increasing demand for the differentiated clinical profile of MYFEMBREE while growing the class.
Approximately 1,400 patients have been treated with MYFEMBREE from launch through November 2021, including patients on commercial drug and free drug programs, excluding patients utilizing product samples.
From launch through December 2021, over 800 unique providers had prescribed MYFEMBREE, of which 58% had not previously prescribed a GnRH antagonist FDA-approved for the treatment of uterine fibroids.
As of January 2022, Myovant achieved 83% commercial coverage for MYFEMBREE. Myovant continues to engage with key commercial payers to maintain coverage as well as to potentially expand coverage with payers yet to make a coverage decision.
RYEQO (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg)

Since regulatory approvals for RYEQO by the European Commission (EC) in July 2021 and Medicines and Healthcare products Regulatory Agency in August 2021, Gedeon Richter (Richter), Myovant’s commercialization partner in certain other international markets, has launched RYEQO in 12 countries.
Third fiscal quarter 2021 net product revenues for RYEQO were $2.4 million, composed of $2.3 million related to product supply to Richter and $0.1 million royalties on net sales of RYEQO in Richter’s Territory.
Ex-U.S. Rights to Relugolix in Oncology

Myovant is continuing to assess partnership opportunities with multiple interested parties for international commercialization and development rights (excluding Canada and certain Asian countries) to relugolix in oncology. Myovant’s goal is to reach agreement with a partner by the anticipated EC approval of relugolix for prostate cancer, expected in mid-calendar year 2022.
Board of Director Appointment

Effective on November 5, 2021, Dr. Nancy Valente, M.D. was appointed by Myovant’s Board as an independent director following Ms. Kathleen Sebelius’ retirement from Myovant’s Board. Dr. Valente also became a member of the Audit Committee and the Chair of the Nominating and Corporate Governance Committee of Myovant’s Board.
Expected Upcoming Milestones

FDA submission of the Phase 3 LIBERTY randomized withdrawal study results for MYFEMBREE in women with uterine fibroids is expected in the first quarter of calendar year 2022.
Two-year data from the SPIRIT long-term extension study of MYFEMBREE in women with endometriosis-associated pain is expected in the first quarter of calendar year 2022.
FDA decision for the MYFEMBREE sNDA seeking approval for the management of moderate to severe pain associated with endometriosis is expected by its May 6, 2022 target action date. FDA approval of MYFEMBREE for this indication would trigger a $100.0 million regulatory milestone payment from Pfizer. If approved by May 6, 2022, Myovant and Pfizer expect to launch MYFEMBREE in the U.S. for this indication in May 2022. If approved, this indication would utilize the same dosage, formulation, administration, and branding as MYFEMBREE, which was previously approved by the FDA in May 2021 for the management of heavy menstrual bleeding associated with uterine fibroids.
EC decision on the advanced prostate cancer Marketing Authorisation Application is expected in mid-calendar year 2022.
European Medicines Agency regulatory submission for RYEQO for the treatment of women with endometriosis-associated pain is expected in calendar year 2022. Richter will be the sponsor.
Third Fiscal Quarter 2021 Financial Summary

Total revenues for the three months ended December 31, 2021 were $54.4 million compared to $1.4 million for the three months ended December 31, 2020.

Product revenue, net from sales of ORGOVYX and MYFEMBREE in the U.S. for the three months ended December 31, 2021 were $24.4 million and $2.4 million, respectively. For the three months ended December 31, 2021 product revenue, net also includes revenues related to product supply to Richter of $2.3 million, as well as royalties on net sales of RYEQO in Richter’s Territory of $0.1 million. There was no such revenue recorded in the comparable prior year period.
Pfizer collaboration revenue for the three months ended December 31, 2021 was $25.2 million, reflecting the partial recognition of the upfront payment Myovant received from Pfizer upon entering into the Pfizer Collaboration and License Agreement in December 2020 and of the regulatory milestone payment from Pfizer that was triggered upon the FDA approval of MYFEMBREE for the management of heavy menstrual bleeding associated with uterine fibroids in May 2021. Pfizer collaboration revenue in the three months ended December 31, 2020 was $1.4 million, reflecting the partial recognition of the upfront payment received from Pfizer.
Cost of product revenue for the three months ended December 31, 2021 was $4.2 million related to the cost of goods sold and royalty expense payable to Takeda pursuant to the Takeda License Agreement. There were no such amounts recognized in the comparable prior year period.

Collaboration expense to Pfizer for the three months ended December 31, 2021, was $12.1 million, reflecting Pfizer’s 50% share of net profits from sales of ORGOVYX and MYFEMBREE in the U.S., pursuant to the Pfizer Collaboration and License Agreement. There were no such amounts recognized in the comparable prior year period.

Research and development (R&D) expenses for the three months ended December 31, 2021, were $25.7 million compared to $30.5 million for the comparable prior year period. The decrease in R&D expenses primarily reflects a reduction in clinical study costs as a result of the completion and wind down of Myovant’s Phase 3 LIBERTY, HERO, and SPIRIT studies, as well as higher cost sharing with Pfizer for certain R&D expenses.

Selling, general and administrative (SG&A) expenses for the three months ended December 31, 2021, were $72.1 million compared to $49.2 million for the comparable prior year period. The increase was primarily due to higher expenses to support the ORGOVYX and MYFEMBREE U.S. launches, including higher personnel-related costs primarily due to the hiring of Myovant’s commercial operations, marketing, and market access teams, as well as the oncology and women’s health sales forces.

Interest expense was $3.5 million for the three months ended December 31, 2021, compared to $2.6 million for the comparable prior year period. The increase in interest expense was primarily driven by the higher balance under Myovant’s loan agreement with Sumitomo Dainippon Pharma (Sumitomo Dainippon Pharma Loan Agreement) and $0.6 million of accretion of the financing component of the cost share advance from Pfizer.

Foreign exchange gain for the three months ended December 31, 2020 was $5.9 million, primarily the result of the impact of fluctuations in the foreign currency exchange rate between the Swiss franc and the U.S. dollar on Myovant’s outstanding balance under the Sumitomo Dainippon Pharma Loan Agreement. As a result of a change in the functional currency of Myovant’s wholly-owned subsidiary in Switzerland, Myovant Sciences GmbH, from the Swiss franc to the U.S. dollar in December 2020, Myovant is no longer exposed to significant foreign currency gains or losses.

Net loss for the three months ended December 31, 2021 was $63.4 million compared to $73.8 million for the comparable prior year period. On a per common share basis, net loss was $0.68 and $0.82 for the three months ended December 31, 2021 and 2020, respectively.

Capital resources: Cash, cash equivalents, marketable securities, and amounts available under the Sumitomo Dainippon Pharma Loan Agreement totaled $569.1 million as of December 31, 2021, and consisted of $527.8 million of cash, cash equivalents, and marketable securities and $41.3 million of available borrowing capacity under the Sumitomo Dainippon Pharma Loan Agreement.

Conference Call
As previously announced, Myovant will hold a webcast and conference call at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) today, January 26, 2022, to discuss financial results for its third fiscal quarter ended December 31, 2021 and corporate updates. Investors and the general public may access a live webcast of the call by visiting the investor relations page of Myovant’s website at investors.myovant.com. Institutional investors and analysts may also participate in the conference call by dialing 1-800-532-3746 in the U.S. or +1-470-495-9166 from outside the U.S. The webcast will be archived on Myovant’s investor relations website following the call.

About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone, a hormone known to stimulate the growth of prostate cancer, and ovarian estradiol, a hormone known to stimulate the growth of uterine fibroids and endometriosis. ORGOVYX (relugolix 120 mg) was approved in the U.S. by the FDA in December 2020 as the first and only oral GnRH receptor antagonist for the treatment of adult patients with advanced prostate cancer, and relugolix (120 mg) is also under regulatory review in Europe for men with advanced prostate cancer. MYFEMBREE (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) was approved in the U.S. by the FDA in May 2021 as the first and only once-daily oral treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months, and by the European Commission and the Medicines and Healthcare products Regulatory Agency in July 2021 and August 2021, respectively, as RYEQO for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age, with no limitation for duration of use. In September 2021, the FDA accepted Myovant’s supplemental New Drug Application for MYFEMBREE for the management of moderate to severe pain associated with endometriosis, setting a target action date of May 6, 2022. MYFEMBREE is also being assessed for contraceptive efficacy in women with endometriosis or uterine fibroids who are 18 to 50 years of age and at risk for pregnancy.

On January 26, 2022, Epizyme, Inc. (the "Company") reported that entered into an underwriting agreement (the "Underwriting Agreement") with Jefferies LLC, as representative of the several underwriters listed therein (collectively, the "Underwriters"), relating to an underwritten public offering (the "Offering") of 56,666,667 shares (the "Shares") of the Company’s common stock, par value $0.0001 per share (the "Common Stock") at a public offering price of $1.50 per share. All of the Shares are being sold by the Company (Filing, 8-K, Epizyme, JAN 26, 2022, View Source [SID1234607443]). The Underwriters have agreed to purchase the Shares from the Company pursuant to the Underwriting Agreement at a price of $1.41 per share. Under the terms of the Underwriting Agreement, the Company has also granted the Underwriters an option, exercisable for 30 days, to purchase up to an additional 8,500,000 shares of Common Stock (the "Additional Shares"), at the same price per share as the Shares.

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The Company estimates that the net proceeds from the Offering will be approximately $79.5 million, or approximately $91.4 million if the Underwriters exercise in full their option to purchase Additional Shares, in each case, after deducting underwriting discounts and commissions and estimated offering expenses. Based on the Company’s research and development plans and its timing expectations related to the progress of its programs, the Company expects that the net proceeds from the Offering, together with the Company’s existing cash, cash equivalents and marketable securities as of December 31, 2021, and product revenue the Company expects to generate from product sales, will enable the Company to fund its operating expenses and capital expenditure requirements into the third quarter of 2023.

The Shares, and any Additional Shares, will be issued pursuant to a prospectus supplement dated January 26, 2022 and an accompanying base prospectus dated May 13, 2021 that form a part of the registration statement on Form S-3 that the Company filed with the U.S. Securities and Exchange Commission ("SEC") (File No. 333-255806), which was declared effective by the SEC on May 13, 2021. The closing of the Offering is expected to take place on or about January 31, 2022, subject to the satisfaction of customary closing conditions.

The Underwriting Agreement contains customary representations, warranties, covenants and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties. A copy of the Underwriting Agreement is attached as Exhibit 1.1 hereto and is incorporated herein by reference. The foregoing description of the material terms of the Underwriting Agreement does not purport to be complete and is qualified in its entirety by reference to such exhibit.

On January 26, 2022 Nordic Pharma reported that on the 24th of January, the European Commission (EC) approved the new indication for Teysuno (tegafur/gimeracil/oteracil) for the treatment of patients with metastatic colorectal cancer who cannot continue fluoropyrimidine treatment due to specific toxicities: hand-foot syndrome and cardiotoxicity (Press release, Nordic Pharma, JAN 26, 2022, View Source [SID1234607539]).

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Nordic Pharma received a positive scientific opinion recommending approval of the use of Teysuno in metastatic colorectal cancer from EMA’s Committee for Medicinal Products for Human Use (CHMP) in December 2021.

Based on this approval, Teysuno will be indicated in adults:

for the treatment of advanced gastric cancer when given in combination with cisplatin (current indication).
as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting

New fluoropyrimidine for patients with metastatic colorectal cancer

nordic_pharma_thumbnail_green_colon

In metastatic colorectal cancer the typical first-line chemotherapy consists of a fluoropyrimidine used in various combinations.

Teysuno is an oral fluoropyrimidine with similar efficacy, but improved specific safety profile compared with other fluoropyrimidines.

Jean-Michel Quinot, CEO of Nordic Pharma stated: "This is important news for patients with metastatic colorectal cancer. Teysuno offers those patients suffering from toxicities that can cause discontinuation of therapy an alternative fluoropyrimidine therapy which allows them to continue systemic treatment that is known to significantly prolong survival. By being able to meet this medical need, we hope to contribute to improving the lives of these patients. We want to particularly thank medical oncologists and patients in different European countries who contributed to collecting crucial clinical data for this new indication."

Iris van Lakerveld, Global Oncology Lead added: "Fluoropyrimidines are, and will continue to be, the cornerstone of chemotherapy treatment in metastatic colorectal cancer. A significant group of patients can now be offered an alternative, in the event that chemotherapy needs to be delayed, the dose reduced or fully stopped because of hand-foot syndrome or cardiotoxicity. Side effects with chemotherapy are inevitable. With Teysuno, physicians and patients will have an additional therapy when needed, allowing optimal benefit of fluoropyrimidine treatment.

Nordic Pharma licences Teysuno from Taiho Pharmaceutical Co., Ltd. in Japan. In Japan, the product is known as TS-1 and is approved for various solid tumours, including gastric and colorectal cancer. Since 2011 Teysuno has been on the European market in 17 countries. In total, the product is marketed in over 30 countries worldwide. The approval of the European Commission is an important step in providing patients with metastatic colorectal cancer access to Teysuno. Subsequently country-specific reimbursement applications will be done at the level of each Member State to ensure this access.

On January 25, 2022 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx) targeting oncology and immuno-dysregulated diseases, reported data showing that IMX-110 + anti-PD-1 produced 63-day median survival in a genetic pancreatic cancer mouse model in which mice develop their own pancreatic cancer and have an intact immune system (Press release, Immix Biopharma, JAN 25, 2022, View Source [SID1234606772]). Historically, according to Winograd et al., 2015, 42-days is the median survival produced by a 4-drug combination: 2 chemotherapies (gemcitabine, nab-paclitaxel) and 2 immunotherapies (anti-PD-1, anti-CD40) in the same genetic pancreatic cancer mouse model.

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"This data highlights why we are excited to collaborate with BeiGene on our planned 2022 Phase 1b/2a combination clinical trial of IMX-110 + BeiGene anti-PD-1 tislelizumab in advanced solid tumors," said Ilya Rachman, MD PhD, CEO of ImmixBio. "We believe this upcoming combination clinical trial will allow us to rapidly expand into multiple oncology indications."

The U.S. Food and Drug Administration ("FDA") has approved orphan drug designation ("ODD") for IMX-110 for the treatment of soft tissue sarcoma. Additionally, the FDA has approved rare pediatric disease ("RPD") designation to IMX-110 for the treatment of a life-threatening pediatric cancer in children, rhabdomyosarcoma.

In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize anti-PD-1 tislelizumab in North America, Europe, and Japan in exchange for an upfront payment by Novartis of US$650 million plus royalties and milestone payments.

As of January 2022, anti-PD-1 tisleizumab has been approved or granted conditional approval in 6 cancer indications in China, including non-squamous non-small cell lung cancer ("NSCLC"), squamous NSCLC, classical Hodgkin’s lymphoma, Hepatocellular Carcinoma, and urothelial carcinoma.

On January 25, 2022 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company dedicated to delivering targeted therapies for rare cancers, reported that it intends to offer and sell $100.0 million of shares of its common stock in an underwritten public offering (Press release, Sierra Oncology, JAN 25, 2022, View Source [SID1234606788]). The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the offering. In addition, Sierra Oncology intends to grant the underwriters a 30-day option to purchase up to $15.0 million of additional shares of its common stock. Sierra Oncology intends to use the net proceeds of the offering to prepare for potential commercialization of momelotinib, clinical development activities of its other product candidates, research, clinical and process development and manufacturing of its product candidates, working capital, and capital expenditures and other general corporate purposes.

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Jefferies and Cantor are acting as the joint book-running managers for the proposed offering. LifeSci Capital, Oppenheimer & Co. and H.C. Wainwright & Co. are acting as lead managers for the proposed offering.

A shelf registration statement on Form S-3 relating to the common stock offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on November 5, 2021 and declared effective by the SEC on November 12, 2021. A preliminary prospectus supplement and the accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this proposed offering may also be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, New York, New York 10022, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.