On September 29, 2020 Tmunity Therapeutics, Inc., a private clinical-stage biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T-cell immunotherapy, reported that President & CEO Usman "Oz" Azam is scheduled to present at two upcoming virtual investor conferences (Press release, Tmunity Therapeutics, SEP 29, 2020, View Source [SID1234567742]).​

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Chardan 4th Annual Genetic Medicines Conference

Date:

Monday, October 5, 2020

Time:

1:30 pm ET

Location:

Presentation will be via webcast

Alliance of Regenerative Medicine 2020 Virtual Cell & Gene Meeting on the Mesa

Date:

Monday, October 12 – Friday, October 16

Time:

Company presentations will be available to view on-demand throughout the entirety of the conference

Location:

Please visit www.meetingonthemesa.com for full information including registration.

On September 29, 2020 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported results of an additional secondary endpoint from the Phase 3 HERO study evaluating relugolix in men with advanced prostate cancer (Press release, Myovant Sciences, SEP 29, 2020, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-announces-results-additional-secondary-endpoint [SID1234567739]). Relugolix did not achieve statistical superiority for castration resistance-free survival compared to leuprolide acetate in men with metastatic disease through 48 weeks.

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"These new data from the Phase 3 HERO study show that three out of four men with metastatic prostate cancer remained castration resistance-free through 48 weeks while on oral relugolix, in-line with leuprolide acetate injections, the current standard of care," said Dan George, M.D., a professor of medicine and surgery at the Duke University School of Medicine and HERO program steering committee member. "I continue to be excited by relugolix as a potential new and differentiated treatment option for men with prostate cancer given its robust clinical and safety data, including the lower risk of major adverse cardiovascular events compared to leuprolide acetate."

Castration-resistant prostate cancer is defined by disease progression despite achieving testosterone suppression to castrate levels (< 50 ng/dL). In the subgroup of men with metastatic disease treated with relugolix, 74% were castration-resistance free through 48 weeks compared to 75% men treated with leuprolide acetate (HR = 1.03 [95% CI: 0.68-1.57]; p = 0.84). In the secondary endpoint analysis, castration resistance-free survival was defined as the time from first dose to prostate-specific antigen (PSA) progression per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria or death from any cause. PSA progression was defined as a PSA increase ≥ 25% and ≥ 2 ng/mL above the nadir, and confirmed by a second PSA value ≥ 3 weeks later.

"We believe the totality of data – including previously reported data from the Phase 3 HERO program, published in the New England Journal of Medicine – presents compelling evidence for the potential use of relugolix in men with advanced prostate cancer," said Lynn Seely, M.D., chief executive officer of Myovant Sciences. "With our New Drug Application under Priority Review by the FDA, we look forward to our target action date in December 2020 and hope to advance our commitment to redefining care by bringing once-daily, oral relugolix to men with prostate cancer."

The incidence of adverse events in the subgroup of men with metastatic disease was consistent with that observed in primary analysis of HERO with no new safety signals observed.

Relugolix (120 mg) is under Priority Review by the FDA for the treatment of men with advanced prostate cancer, with a target action date of December 20, 2020. In the Phase 3 HERO study, relugolix met the primary efficacy endpoint, with 96.7% of men treated with relugolix achieving sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks versus 88.8% of men treated with leuprolide acetate. Relugolix also met six key secondary endpoints, demonstrating rapid and profound suppression of testosterone and PSA response, in addition to improved testosterone recovery after discontinuation of treatment. Men in the relugolix group had a 54% lower risk of major adverse cardiovascular events (MACE) compared to men in the leuprolide acetate group (2.9% vs. 6.2%, respectively). In men with a reported history of MACE, the relugolix group had 80% fewer MACE events reported compared to the leuprolide acetate group (3.6% vs. 17.8%, respectively). The overall incidence of adverse events in the relugolix and leuprolide acetate groups was comparable (92.9% vs. 93.5%, respectively).

About the Phase 3 HERO Program in Advanced Prostate Cancer
Myovant’s Phase 3 clinical program for advanced prostate cancer consisted of a randomized, open-label, parallel-group, multinational clinical study designed to evaluate the safety and efficacy of relugolix in over 900 men with androgen-sensitive advanced prostate cancer who required at least one year of continuous androgen deprivation therapy. Men were randomized 2:1 to receive a single loading dose of relugolix 360 mg followed by relugolix 120 mg once daily, or to treatment with leuprolide acetate 3-month depot injection, respectively.

About Prostate Cancer
Prostate cancer is the second most prevalent form of cancer in men and the second leading cause of death due to cancer in men in the U.S. Cardiovascular mortality is the leading cause of death in men with prostate cancer and accounts for 34% of deaths in men with prostate cancer in the U.S. More than three million men in the U.S. are currently living with prostate cancer, and approximately 190,000 men are estimated to be newly diagnosed in 2020.

Advanced prostate cancer is prostate cancer that has spread or come back after treatment and may include men with biochemical recurrence (rising PSA in the absence of metastatic disease on imaging), locally advanced disease, or metastatic disease. Front-line medical therapy for advanced prostate cancer typically involves androgen deprivation therapy, which reduces testosterone to very low levels, commonly referred to as castrate levels. GnRH receptor agonists, such as leuprolide acetate, are depot injections and the current standard of care for androgen deprivation therapy. However, GnRH receptor agonists may be associated with mechanism-of-action limitations, including the potentially detrimental initial surge in testosterone levels that can exacerbate clinical symptoms, which is known as clinical or hormonal flare, and delayed testosterone recovery after the drug is discontinued. Approximately 210,000 men are treated with androgen deprivation therapy with a GnRH agonist or antagonist each year.

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. Relugolix monotherapy tablet (120 mg) is under regulatory review in the U.S. for men with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis.

On September 29, 2020 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that the company’s management will present at the Jefferies Virtual Cell Therapy Conference on Tuesday, October 6 at 8:00 a.m. Eastern Time (Press release, Affimed, SEP 29, 2020, View Source [SID1234567738]).

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A live webcast of the presentation can be accessed under the "Investors" section of Affimed’s website at View Source and will be available for 30 days following the event.

On September 29, 2020 PMV Pharmaceuticals, Inc., a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutations, reported the closing of its initial public offering of 13,529,750 shares of common stock, which includes the exercise in full by the underwriters of their option to purchase 1,764,750 additional shares of common stock, at a public offering price of $18.00 per share (Press release, PMV Pharma, SEP 29, 2020, View Source [SID1234567731]). The aggregate gross proceeds to PMV Pharma from the offering were approximately $243.5 million, before deducting underwriting discounts and commissions and other offering expenses. All of the shares in the offering were offered by PMV Pharma. PMV Pharma’s common stock is listed on the Nasdaq Global Select Market under the ticker symbol "PMVP."

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Goldman Sachs & Co. LLC, BofA Securities, Cowen and Evercore ISI acted as joint book-running managers for the offering.

A registration statement relating to the shares sold in the offering was filed with the Securities and Exchange Commission and became effective on September 24, 2020. The offering was made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, copies of the prospectus, when available, may be obtained for free from the offices of Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at 1-866-471-2526, or by email at [email protected]; BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255, or by email at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at 1-833-297-2926, or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at 1-888-474-0200, or by email at [email protected].

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

On September 29, 2020 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTCQB: IPATF) reported financial results for its fiscal year 2021 first quarter ended July 31, 2020 (Press release, ImmunoPrecise Antibodies, SEP 29, 2020, View Source [SID1234567730]).

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Q1 Fiscal 2021 Financial Highlights:

• Revenue increases by $1.1 million, or 39%, to $3.8 million versus $2.7 million for Q1 2020
• Gross profit increases by $1.1 million to 64% of revenue vs 51% of revenue for the prior year period.
• Adjusted EBITDA increases to $932,000 compared to a loss of $481, 000 for the same period last year.
• Cash on hand is $6.0 million as of July 31, 2020.
• Warrants exercised after quarter-end through September 28, 2020 provide $9.7 million in cash in exchange for 7.8 million shares of stock, all warrants expiring September 24, 2020 were exercised.

Financial Results

Revenue. The Company achieved revenues of $3,764,977 during the three months ended July 31, 2020, compared to revenues of $2,716,099 during the same quarter in 2019. This represents a 39% increase in revenue for the period. The increasing revenue trend is due to increases in both volume and financial value of client contracts as a result of continued focus on expanding the breadth and depth of services offered, new client onboarding including top pharma companies, and growing its core existing client business.

Gross Margin. During the three months ended July 31, 2020, the Company achieved a gross profit of $2,410,326, compared to $1,376,406 in 2019. This represents a 64% increase compared to 51% for the same period last year.

Net Loss. The Company recorded a net loss of $549,318 during the three months ended July 31, 2020, compared to net loss of $2,012,198 for the three months ended July 31, 2019, primarily due to higher revenue and gross profit as well as an increase in Other Income as a result of research grant awards and government subsidies.

Non-IFRS Measures. * Adjusted EBITDA for the three months ended July 31, 2020 was $932,716 compared to ($481,499) for same period last year. This significant improvement in Adjusted EBITDA is primarily a result of the increase in gross profit and research grant awards and government subsidies.

Warrant Exercises. During the first quarter, 3,305,500 warrants were exercised issuing shares of common stock for $3,566,474 in cash. Subsequent to quarter-end, 7,813,000 warrants were exercised issuing shares of common stock for $9,725,000 in cash. All warrants expiring September 24, 2020 were exercised.

Dr. Jennifer Bath, CEO and President of ImmunoPrecise, commented, "This has been a transformative quarter, both financially and operationally. We achieved solid revenues, as we added new clients and expanded services with our existing clients. As a result, we achieved positive adjusted EBITDA and cash flow from operations. At the same time, we have further strengthened our balance sheet and enhanced our capital structure through the exercise of warrants, providing the opportunity to generate more intellectual property assets."

"Operationally, we continue to make tremendous progress, advancing programs both with our clients as well as our proprietary COVID-19 programs. We recently announced an important research collaboration with Zymeworks Inc., providing us access to their Zymeworks’ Azymetric and EFECT platforms for the further development of multiple antibody candidates to fight COVID-19. Most recently, we announced the initiation of pre-clinical vaccine trials against SARS-CoV-2 together with LiteVax BV (Oss, the Netherlands). Overall, we are rapidly advancing our Polytope Therapy and Vaccine programs, which we believe represent the most comprehensive and diverse antibody cocktail approach globally."

"Given our financial and operational progress, we felt this was the appropriate time to commence our NASDAQ listing process. As the world’s pre-eminent exchange for biotech and pharma companies, we believe a NASDAQ listing will provide us greater exposure within the investment community as we execute on key upcoming milestones."

IPA periodically provides information for investors on its corporate website, www.immunoprecise.com. This includes press releases and other information on financial performance, reports filed or furnished with the TSX, information on corporate governance and details related to its annual meeting of shareholders. Reports filed or furnished with the TSX can be found at www.sedar.com.