On December 9, 2020 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported the pricing of an underwritten public offering of 5,434,783 shares of its common stock at a price to the public of $23.00 per share (Press release, Syndax, DEC 9, 2020, View Source [SID1234572493]). The gross proceeds to Syndax from this offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $125 million. The offering is expected to close on December 11, 2020, subject to customary closing conditions. Additionally, Syndax granted the underwriters a 30-day option to purchase up to 815,217 additional shares of common stock at the public offering price, less underwriting discounts and commissions. All of the shares of common stock in the offering will be sold by Syndax.

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Goldman Sachs & Co. LLC, Citigroup and Cowen are acting as joint book-running managers for the offering. BTIG is acting as lead manager for the offering. Baird is acting as co-manager for the offering.

The shares are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the website of the SEC at www.sec.gov. When available, copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Goldman Sachs and Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; or Citigroup Global Markets Inc., c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, or by phone at (800) 831-9146; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by email at [email protected], or by phone at (833) 297-2926.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, 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. Any offer, if at all, will be made only by means of a prospectus supplement and accompanying prospectus, which are a part of the effective registration statement.

On December 9, 2020 Oasmia reported that Interim report1 for the period May 1, 2020 – October 31, 2020(Press release, Oasmia, DEC 9, 2020, View Source [SID1234572492])

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SIGNIFICANT EVENTS DURING THE SECOND QUARTER
In August Oasmia appointed Peter Selin as Chief Business Officer.
Oasmia’s CFO Michael af Winklerfelt resigned from his role in August and Fredrik Järrsten was appointed as Chief Financial Officer in September.
In September Oasmia’s Nomination Committee revised its proposal for the AGM regarding Board of Directors and Sven Rohmann notified that he is no longer available for re-election.
In September Oasmia brought an action against the company’s former Board of Directors as a direct result of findings from an investigation into the former Board of Directors’ responsibilities by the auditing firm Deloitte.
In October Oasmia’s partner Elevar Therapeutics signed an agreement with Taiba Middle East FZ LLC for commercialization of Apealea in the Middle East and North Africa Region.
In October the disciplinary committee of Nasdaq Stockholm ordered Oasmia to pay a fine due to the former Board of Directors, in connection with the EGM in March 2019, in several respects violating generally accepted behavior in the securities market.
Oasmia announced in October that the company has continued to secure IP rights, including the approval of XMeNa patent in India and soon in Australia as well as approved Apealea trademark registrations in Switzerland, Israel, South Africa, Malaysia and Indonesia.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
In November Robert Maiorana joined Oasmia as acting CFO, with effect from December 1, 2020 until Fredrik Järrsten commenced in the role. Thereafter, Robert will work as Finance Manager and support Fredrik.
On 3rd December Oasmia shared an update from its partner Elevar Therapeutics on the development plan for Apealea (paclitaxel micellar) in ovarian cancer.
SECOND QUARTER[2]: AUGUST 1, 2020 – OCTOBER 31, 2020
Consolidated net sales amounted to TSEK 154 (252)
Operating profit/loss was TSEK -53,693 (-47,436)[3]
Net profit/loss after tax amounted to TSEK –53,538 (-18,309)[3]
Earnings per share was SEK -0.12 (-0.06)[3],[4]
THE PERIOD2: MAY 1, 2020 – OCTOBER 31, 2020
Consolidated net sales amounted to TSEK 362 (433)
Operating profit/loss was TSEK -102,914 (-83 201)[3]
Net profit/loss after tax amounted to TSEK –106,643 (-58,093)[3]
Earnings per share was SEK -0.24 (-0.18)[3,4]
CEO’S COMMENTS
The last quarter at Oasmia has seen us focusing on building on the solid foundations we have laid so far this year following the implementation of recommendations highlighted by the strategic review initiated following my appointment as CEO in March. Since then, we have focused our activities on R&D and lab testing in line with our new strategy and reduced our rate of cash burn as the consequence of the rightsizing of our Company. Throughout the period we have continued to make progress on delivering our vision of creating a sustainable specialty pharma company.

In early December Elevar Therapeutics, our global strategic partner shared an update on the development plan for Apealea (paclitaxel micellar) in ovarian cancer. Following interactions with the FDA Elevar has decided to complete two new studies with Apealea which will be initiated in the first half of 2021 before filing the new drug application (NDA). These studies of Apealea may potentially help to secure a successful registration in the U.S. and provide new data to support a strong product label.

Over the period we have also been working with Elevar to support their partnering efforts for Apealea in key global territories. In October, Elevar announced an agreement with Taiba Middle East FZ LLC for the commercialization of Apealea in the Middle East and North Africa region. This is the first regional partnership deal for Apealea and Elevar is in late stage discussions with a number of potential partners for other regions around the world. Most recently, Elevar and Tanner Pharma Group announced the launch of a global Named Patient program to provide access to Apealea in areas outside of the United States and Middle East North Africa (MENA) where Apealea is not yet commercially available.

As previously communicated Oasmia retains marketing rights for Apealea in the Nordic countries and has made the product commercially available earlier this year. The COVID-19 pandemic continues to significantly impact the ability of our medical scientific liaisons to meet oncologists in the Nordics. However, we are pleased to report that as of November we have started to record initial sales in Finland. In Sweden a positive interest for Apealea has been shown in a few centres in a highly competitive oncology ward environment that is mostly closed to any face-to-face interactions with the Industry. In Denmark, against a negative outcome from the health technology assessment submission we are working on alternatives to generate clinical data.

A central pillar of our new strategy is to explore licensing and partnering opportunities for our existing assets. To drive this process forward in a timely manner I have appointed consultancy firms that will aid us in finding and selecting partners for our Animal Health division as well as the wider XR-17 platform.

To maximise the value of our platform we have hired a strategic firm to assist Oasmia and facilitate analysis, selection and engagement with potential partners related to licensing/M&A. A four-step project has therefore been initiated with developing a positioning analysis of the XR-17 platform against competing alternatives based on identification and validation of perceived industry needs among potential licensees.

I have also appointed an international investment bank focusing on healthcare with animal health experts to provide us strategic advisory services related to our Animal Health portfolio.

Our pipeline of development programmes continues to progress well. Docetaxel micellar is poised to enter on time in clinical development for advanced prostate cancer with the renowned Swiss Group for Clinical Cancer Research (SAKK). We are also working on adding a novel product candidate in pre-clinical development, using our XR-17 technology. I hope to be able to disclose further details soon provided a positive outcome.

Protecting intellectual property is critical at any innovative company in our sector, and during the period we worked to bolster our already strong position in this area. In October we announced that our XMeNa patent was approved in India and will soon to be approved in Australia. The XMeNa patent protects an improved method for producing our technology platform XR-17, which is a unique carrier system for anticancer drugs. We have also secured new trademark registrations for Apealea in Switzerland, Israel, South Africa, Malaysia and Indonesia during the year.

A key objective for Oasmia is to ensure that we have the right people in place to execute our plans and deliver success. We have made several senior level executive appointments over the last few months including the appointment of two senior scientists to our technical operations team. We believe that investing in this crucial area of the business will enable us to further develop and potentially upgrade our XR-17 platform.

In September we announced that Peter Selin would be joining us as Chief Business Officer and he is now on board since the start of November. His expertise in business development and strategy in the life sciences sector will be invaluable to Oasmia as we continue to pursue growth by seeking M&A and licensing opportunities that complement our technology and business model. Another key addition to the team, announced in October, was the appointment of Fredrik Järrsten as Chief Financial Officer. He has over 25 years of experience across the financial, medical technology and life sciences sectors in the Nordic region and internationally. I know that Fredrik will be an incredible asset to Oasmia when he joins us early next year.

With this experienced new senior team in place I look forward to the remainder of 2020 and beyond with confidence and optimism. Oasmia is in great shape to deliver our strategic objectives as a business and I look forward to keeping you up to date on our progress.

Dr. Francois Martelet, M.D., CEO of Oasmia

The report is available on the company’s website: View Source

Conference call
The company will hold a conference call and an online presentation on December 9, 2020 at 10.00 am CET. The call will be hosted by CEO Francois Martelet, CEO and Acting CFO Robert Maiorana. The presentation will be in English.
The conference call will be broadcast live on the web via the link:
View Source

On December 9, 2020 Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology company, reported to share top-line final data from its phase I study of Cantrixil (TRX-E-002-1) in patients with persistent or recurrent ovarian cancer (NCT02903771) (Press release, Kazia Therapeutics, DEC 9, 2020, View Source [SID1234572491]).

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Key Points

25 patients with advanced metastatic ovarian cancer received at least one dose of Cantrixil at six sites in the United States and Australia, comprising 11 patients in Part A (dose escalation) and 14 patients in Part B (dose expansion)

Trial achieved its primary objective, determining the maximum tolerated dose (MTD) of Cantrixil to be 5 mg/kg

Overall, 16 patients were evaluable for efficacy. One patient demonstrated a complete response (CR) and two patients experienced a partial response (PR), according to industry-standard RECIST criteria, making an overall response rate (ORR) of 19%

The patient who experienced a complete response remains in remission some three years after her last dose of Cantrixil

The drug was generally well-tolerated, with primarily gastrointestinal toxicities observed (abdominal pain, vomiting, and nausea)

Australian lead investigator, Associate Professor Jim Coward, commented, "this was a heavily pre-treated population, comprising patients with very advanced disease. Existing treatment options for such patients are limited, and there remains an urgent need for new therapies. My colleagues and I are excited by the potential for Cantrixil to provide benefit here, and we look forward to seeing the drug move forward in its development."

Kazia expects the full data to be presented at a suitable academic conference and published in a peer-reviewed journal in 1H CY2021. In accordance with common practice, the full data will remain embargoed until they are formally published, in order not to prejudice the appropriate dissemination of the data, and only top-line data are discussed here.

Kazia CEO, Dr James Garner, commented, "we are very pleased to see the Cantrixil phase I study completed. The data unambiguously demonstrates the potential for Cantrixil to provide benefit in this very challenging patient population. With this positive data in hand, our focus now shifts to partnering activity, and we hope to transition Cantrixil to a company which both shares our belief in its potential and is able to apply the necessary resources and expertise to realise that potential over the next chapter of its development."

Background

The phase I study of Cantrixil in ovarian cancer (NCT02903771) commenced recruitment in December 2016. It was designed in two parts. Part A (dose escalation component) was intended to determine the maximum tolerated dose (MTD) of Cantrixil in women with ovarian cancer. Part B (dose expansion cohort) was intended to seek preliminary evidence of clinical efficacy, as well as providing a deeper understanding of pharmacokinetics and safety of Cantrixil. All patients received two cycles of treatment with Cantrixil monotherapy, followed by up to six cycles in combination with other chemotherapy agents.

Kazia announced completion of Part A in October 2018. At that stage, the study declared 5 mg/kg to be the MTD, and this dose was used for all patients in Part B. The main dose-limiting toxicity (DLT) was abdominal pain. 11 patients received at least one dose of Cantrixil in Part A.

Part B recruited an additional 14 patients, all of whom were treated at the MTD, with the goal of seeking exploratory signals of potential clinical efficacy. All 14 patients received at least one dose of Cantrixil in Part B. In total, 17 patients across Part A and Part B received Cantrixil at the MTD of 5 mg/kg.

The study completed recruitment in August 2019, and last patient last visit occurred in March 2020. Preliminary efficacy data was presented in September 2019 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting in Barcelona, Spain, and at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Meeting in June 2020.

On December 9, 2020 Invitae (NYSE: NVTA), a leading medical genetics company, reported three studies demonstrating the benefits of genetic testing for all breast cancer patients, impacting treatment decisions and cancer screening for patients and their families (Press release, Invitae, DEC 9, 2020, View Source [SID1234572489]). The studies, which will be presented at the 2020 San Antonio Breast Cancer Symposium (SABCS), add to the evidence supporting universal access to genetic information for all breast cancer patients.

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

"It’s clear that current guidelines are too restrictive and, as a result, many patients with breast cancer whose care could be improved by access to precision medicine approaches are being missed. Universal testing for all patients with solid tumor cancer, including breast cancer, can help inform treatment and improve outcomes for patients," said Robert Nussbaum, M.D., chief medical officer of Invitae. "These data, taken together with many other studies that demonstrate the utility of universal testing for cancer patients, show the time has come to expand testing guidelines to ensure all breast cancer patients and their families can benefit from incorporating genetic information into their care."

In a prospective, multi-center study of breast cancer patients, one in eight patients had inherited genetic variants that could increase their risk of more aggressive disease and inform treatment choices. Despite the patients having inherited genetic variants, testing rates among patients’ families remained low, even when cost was not a barrier. These findings in breast cancer patients were part of a landmark study across various solid tumor cancers recently published in JAMA Oncology.

Findings of a second study at the meeting underscore the impact germline testing can have on patient outcomes. In the longitudinal study, researchers evaluated the clinical outcomes of breast cancer patients who had undergone testing as part of a registry that included patients who met testing criteria and those who did not. Notably, 60% of patients who received targeted chemotherapy based on germline variants were in the group that did not meet testing criteria, highlighting the possibility that certain beneficial treatments and management changes could be inappropriately withheld from patients if restrictive criteria persist.

The third study at the meeting examined select international germline genetic testing criteria from Canada, Australia and the United Kingdom, and its impact on limiting access to testing in patients and their families who may benefit from this information. The study applied the international testing criteria to a cohort of previously tested U.S. breast cancer patients and found that more than 70% of patients with pathogenic variants would have been excluded using current guidelines to allocate germline testing. Furthermore, >80% of the pathogenic variants detected in these out-of-criteria patients were in genes with published management guidelines. This study demonstrates that current international guidelines for genetic testing are overly restrictive and miss actionable findings that could benefit breast cancer patients and their families.

Invitae presentations at 2020 SABCS:

Poster Session 8: Wednesday, December 9 at 8:00 a.m. CT

Pathogenic variants in hereditary cancer syndrome genes are prevalent among breast cancer patients not meeting various ex-U.S. genetic testing guidelines. Presented by Sarah Nielsen, MS, LCGC
Longitudinal clinical outcomes of a multi-center universal genetic testing registry. Presented by Peter Beitsch, MD
Spotlight Poster Discussion 10: Friday, December 11, 2020 at 1:00 p.m. CT

Universal genetic testing in breast cancer patients: A multi-center, prospective study. Presented by Brenda Ernst, MD

On December 9, 2020 IGM Biosciences, Inc. (NASDAQ: IGMS) (IGM) reported the pricing of its upsized underwritten public offering of shares of its common stock at a price to the public of $90.00 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase shares of its common stock at a purchase price of $89.99 per each pre-funded warrant, which represents the per share public offering price of common stock less the $0.01 per share exercise price for each such pre-funded warrant (Press release, IGM Biosciences, DEC 9, 2020, View Source [SID1234572479]). IGM expects to receive total gross proceeds of approximately $200 million from this offering, before deducting the underwriting discounts and commissions and estimated offering expenses payable by IGM. In addition, IGM has granted the underwriters a 30-day option to purchase up to an additional $30.0 million of shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the shares of common stock and pre-funded warrants in the offering will be sold by IGM. The offering is expected to close on or about December 11, 2020, subject to satisfaction of customary closing conditions.

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Jefferies, Stifel, Guggenheim Securities and RBC Capital Markets are acting as joint book-running managers for the offering. Baird and Truist Securities are acting as the lead managers for the offering.

The securities in the offering will be offered by IGM pursuant to a Registration Statement on Form S-3, filed with the Securities and Exchange Commission (SEC) on November 5, 2020 and declared effective on November 12, 2020. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and may be accessed for free through the SEC’s website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained from: 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]; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at [email protected]; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, NY 10017, by telephone at (212) 518-9658 or by email at [email protected]; or RBC Capital Markets, LLC, 200 Vesey Street, 8th Floor, New York, NY 10281-8098; Attention: Equity Syndicate; by telephone at (877) 822-4089 or by email at [email protected].

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