On August 3, 2020 Aileron Therapeutics (NASDAQ:ALRN) reported that Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer, will participate in two upcoming investor conferences this month (Press release, Aileron Therapeutics, AUG 3, 2020, View Source [SID1234565068]).

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Thursday, August 6, 2020
Event: William Blair Biotech Focus Conference 2020
Time: 12:00 pm ET
*Fireside chat

Thursday, August 13, 2020
Event: Canaccord Genuity 40th Annual Growth Conference
Time: 4:30 pm ET
*Company overview and business update presentation

Live webcasts of these events will be available under the Investors and Media section of Aileron’s website at View Source A replay of the webcasts will be archived on Aileron’s website for 30 days following the respective events.

On August 3, 2020 Aileron Therapeutics (NASDAQ:ALRN) reported that it has completed enrollment in the dose optimization expansion cohort of its ongoing open-label Phase 1b clinical study of ALRN-6924 (Press release, Aileron Therapeutics, AUG 3, 2020, View Source [SID1234565067]). Aileron is focused on transforming the experience of chemotherapy for cancer patients by developing and delivering a novel chemoprotective medicine to protect against multiple chemotherapy-induced side effects. The proof-of-concept Phase 1b study is evaluating ALRN-6924 as a therapeutic agent administered ahead of chemotherapy to prevent chemotherapy-induced bone marrow toxicities, such as severe anemia, thrombocytopenia and neutropenia, in patients with p53-mutated small cell lung cancer (SCLC) who are being treated with topotecan. The protocol for this study consists of a phase 1b and a randomized, controlled phase 2; the Phase 1b has two parts: dose optimization and schedule optimization.

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"We’re very encouraged by the data we reported from the dose optimization part of the Phase 1b in June demonstrating ALRN-6924’s potential to shield multiple healthy cell types from chemotherapy-induced damage without limiting the effect of chemotherapy on cancer cells," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron. "Per the interim findings, the 0.3 mg/kg dose of ALRN-6924 achieved the most robust and consistent chemoprotective effects of the three dose levels evaluated. The chemoprotection results were further supported by pharmacodynamic biomarker results also observed in the interim analysis."

Dr. Aivado continued, "We look forward to reporting the final results of the dose optimization part of the Phase 1b, including findings from the 0.3 mg/kg expansion cohort, as well as preliminary results from the recently initiated schedule optimization part of the Phase 1b, in Q4 of this year. We believe that the results from the Phase 1b, along with results from a healthy volunteer study that we plan to initiate in Q3 of this year, will further support and de-risk our plans to develop ALRN-6924 as a chemoprotective agent for patients with multiple cancer types who are treated with various chemotherapies."

In June 2020, Aileron announced positive interim data from the dose optimization part of the Phase 1b study demonstrating that treatment with ALRN-6924 resulted in protective effects against severe chemotherapy-induced anemia and thrombocytopenia in patients across three dose levels (0.3, 0.6, and 1.2 mg/kg) relative to historical controls. In addition, patients treated with 0.3 mg/kg ALRN-6924 also met the protocol-defined criterion for reduction of NCI CTC Grade 3/4 neutropenia to ≤50% in the first treatment cycle, triggering a cohort expansion at this dose level, from six to 14 patients.

As previously guided, in the fourth quarter of 2020, Aileron plans to report final Phase 1b dose optimization data, including data from the dose optimization expansion cohort as well as pharmacodynamic biomarker and tumor efficacy data, in addition to preliminary Phase 1b schedule optimization data. Additionally, in the third quarter or 2020, Aileron plans to initiate enrollment in a healthy volunteer study to determine dosing schedules for ALRN-6924 that will support and further de-risk the company’s long-term vision to provide a chemoprotective medicine for patients with a p53-mutation regardless of cancer type or chemotherapeutic drug. Aileron will continue to carefully monitor the effect of the coronavirus pandemic on its clinical trial sites and the healthcare system, which may impact its planned data announcements.

About the Dose Optimization Expansion Cohort Design

In the dose optimization expansion cohort, which has completed planned enrollment of eight patients, ALRN-6924 is being administered at a 0.3 mg/kg dose level 24 hours before each dose of topotecan. Topotecan is being administered days 1 through 5 every 21 days.

How ALRN-6924 Works to Protect Healthy Cells from Chemotherapy-Induced Damage

ALRN-6924 is being developed by Aileron as a novel chemoprotective medicine to treat and protect healthy cells in patients with cancer that harbors p53-mutations to reduce or eliminate chemotherapy-induced side effects.

Chemotherapy targets cells that are cycling, or undergoing the process of cell division. In cancer cells, the cell cycle is unchecked, which leads to uncontrolled cell proliferation, a hallmark of cancer. Certain types of healthy cells also naturally need to cycle, such as bone marrow cells (which give rise to red blood cells, white blood cells, and platelets), hair follicle cells, skin cells, and cells lining the oral cavity and the gastrointestinal tract. As a result, chemotherapy targets and kills both cycling healthy cells and cycling cancer cells. This, in turn, leads to a spectrum of chemotherapy-induced side effects, from unpleasant to life-threatening.

ALRN-6924, an investigational first-in-class MDM2/MDMX dual inhibitor, is administered to cancer patients shortly before chemotherapy. ALRN-6924 is designed to selectively activate normal p53 protein in patients’ healthy cells, temporarily and reversibly pausing cell cycling to shield healthy cells from chemotherapy. The protection is limited to healthy cells, as ALRN-6924 cannot work in p53-mutated cancer cells given that p53 has lost function in those cells. Therefore, cancer cells continue to cycle uninterrupted, remaining fully susceptible to destruction by chemotherapy.

On August 3, 2020, Achieve Life Sciences, Inc. ("Achieve") reported that it entered into an underwriting agreement (the "Underwriting Agreement") with Lake Street Capital Markets, LLC (the "Underwriter"), pursuant to which Achieve agreed to issue and sell an aggregate of (a) 476,187 shares of its common stock (the "Shares") and (b) pre-funded warrants to purchase 142,857 shares of its common stock (the "Pre-Funded Warrants") to the Underwriters (the "Offering") (Filing, 8-K, OncoGenex Pharmaceuticals, AUG 3, 2020, View Source [SID1234562863]). The Shares will be sold at the public offering price of $10.50 per share. The Pre-Funded Warrants will be sold at a public offering price of $10.499 per Pre-Funded Warrant, which represents the per share public offering price for the Shares less a $0.001 per share exercise price for each such Pre-Funded Warrant. Pursuant to the Underwriting Agreement, Achieve has also granted the Underwriters a 30-day option to purchase up to an additional 92,856 shares of its common stock. The Underwriting Agreement contains customary representations and warranties, conditions to closing, termination provisions and indemnification obligations, including for liabilities under the Securities Act of 1933, as amended. The Offering is being made pursuant to the shelf registration statement on Form S-3 (File No. 333-229019) that was filed by Achieve with the Securities and Exchange Commission ("SEC") on December 26, 2018, and declared effective by the SEC on February 11, 2019, and a related prospectus supplement.

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The Pre-Funded Warrants are exercisable at any time after the date of issuance. A holder of Pre-Funded Warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially own more than 9.99% of the number of shares of common stock outstanding immediately after giving effect to such exercise. A holder of Pre-Funded Warrants may increase or decrease this percentage, but not in excess of 19.99%, by providing at least 61 days’ prior notice to Achieve.

Achieve estimates that net proceeds from the Offering will be approximately $5.9 million, after deducting underwriting discounts and commissions and estimated Offering expenses, and assuming no exercise of the Underwriters’ option to purchase additional shares. Achieve intends to use the net proceeds from the Offering, together with its existing cash, cash equivalents and marketable securities, to fund clinical research and development, and for general working capital. Achieve expects the Offering to close on August 6, 2020, subject to the satisfaction of customary closing conditions.

The Underwriting Agreement is filed as Exhibit 1.1 to this report and the foregoing description of the terms of the Underwriting Agreement is qualified in its entirety by reference to such exhibit. The Pre-Funded Warrant is filed as Exhibit 4.1 to this report and the foregoing description of the terms of the Pre-Funded Warrants is qualified in its entirety by reference to such exhibit. A copy of the opinion of Fenwick & West LLP, relating to the validity of the securities offered in connection with the Offering, is filed with this Current Report on Form 8-K as Exhibit 5.1.

On August 3, 2020 PMV Pharmaceuticals, Inc., a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutations, reported the completion of a $70 million Series D financing round. Avoro Capital, RA Capital Management and Wellington Management Company joined existing investors OrbiMed Advisors, Nextech Invest, Viking Global Investors, and Boxer Capital of Tavistock Group in the round (Press release, PMV Pharma, AUG 3, 2020, View Source [SID1234562779]).

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The proceeds will be used to advance PMV Pharma’s p53 product candidates. p53 is a tumor suppressor protein and the wild type, or normal, p53 protein plays a pivotal role in the body’s natural defense mechanism against cancer and induces a highly organized program of cellular death to prevent the proliferation of potentially cancerous cells.

Mutant p53 proteins can be misfolded and lose their wild type tumor suppressing function. p53 mutations are found in approximately half of all human cancers. PMV Pharma’s mechanism of action seeks to restore p53 to its normal, wild-type function, which could result in the selective killing of mutant cancer cells without affecting normal tissues.

"This financing provides PMV Pharma with the resources to expand our pipeline and to potentially advance multiple p53 therapies into the clinic," said David Mack, Ph.D., President and Chief Executive of PMV Pharma. "We are excited to have new and strong life science investors that include Avoro, RA Capital and Wellington join us in our pursuit of developing meaningful new medicines for cancer patients. The enthusiasm and confidence from our new and existing investors underscore the important advances we have made."

In addition, PMV Pharma announced the appointment of Rich Heyman, Ph.D. as Chair of the Board of Directors. An industry leader, entrepreneur and renowned scientist with a deep knowledge of and broad depth in the field of oncology, Dr. Heyman has more than 25 years of biopharma experience. He currently serves as Board Chair of ORIC Pharmaceuticals and is on the Board of Directors of Gritstone Oncology, Yumanity Therapeutics, Amunix Pharmaceuticals, Metacrine Inc., and Vividion Therapeutics.

Previously, Dr. Heyman was the co-founder and CEO of Aragon Pharmaceuticals and Seragon Pharmaceuticals, two biotech companies focused on discovering and developing therapeutics targeting hormone-dependent cancers. Johnson & Johnson purchased Aragon in 2013 and Genentech/Roche purchased Seragon in 2014.

"We are thrilled to have Rich join PMV Pharma’s Board of Directors as our Chair. His wealth of experience and proven track record of strategic business, scientific and clinical accomplishments will be invaluable as we continue to progress our pipeline of p53 programs towards the clinic," said Dr. Mack.

"PMV has made significant progress in designing small molecules that modulate p53 function, a well-known but previously inaccessible target in oncology," said Dr. Heyman. "The PMV team, its scientific founders and advisors have created potential therapies that could be first-in-class. I am excited to join as Chair of the Board and look forward to continuing to work with this talented team to help advance PMV’s p53 therapies."

On August 3, 2020 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (the "Company"), a specialty biopharmaceutical company commercializing and developing therapeutics and diagnostic tests, reported that it has entered into a securities purchase agreement with several institutional investors in the United States providing for the sale and issuance of approximately 12,427,876 common shares at a purchase price of $0.56325 per common share in a registered direct offering priced at-the-market under Nasdaq rules (Press release, AEterna Zentaris, AUG 3, 2020, View Source [SID1234562748]). The offering is expected to result in gross proceeds to Aeterna Zentaris of approximately $7.0 million.

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Aeterna Zentaris will also issue to the purchasers unregistered warrants to purchase up to an aggregate of 9,320,907 common shares. The warrants will be exercisable for a period of five and one-half years, exercisable immediately following the issuance date and have an exercise price of $0.47 per common share.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The Company intends to use the net proceeds of this offering for general corporate purposes, which includes, among other purposes, the funding of a pediatric clinical trial in the E.U. and U.S. for Macrilen (macimorelin), the investigation of further therapeutic uses of macimorelin and the expansion of pipeline development activities.

The registered direct offering and concurrent private placement is expected to close on or about August 5, 2020, subject to the satisfaction of customary closing conditions.

The common shares described above (but not the warrants or the common shares underlying the warrants) are being offered by Aeterna Zentaris pursuant to a "shelf" registration statement on Form F-3 (File No. 333-232935), which was previously declared effective by the U.S. Securities and Exchange Commission ("SEC") on August 15, 2019. Such common shares may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

A prospectus supplement relating to the common shares will be filed by Aeterna with the SEC. When filed with the SEC, copies of the prospectus supplement and the accompanying prospectus relating to the registered direct offering, may be obtained at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and accompanying prospectus relating to the registered direct offering may also be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996 or by email at [email protected].

The warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "Act"), and, along with the common shares issuable upon their exercise, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.