On November 10, 2021 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported financial results for the third quarter ended September 30, 2021, and provided a business update (Press release, Nuvation Bio, NOV 10, 2021, View Source [SID1234595148]).

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"In the third quarter, Nuvation Bio continued to advance our lead cyclin-dependent kinase (CDK) 2/4/6 inhibitor program, with enrollment progressing in the ongoing Phase 1/2 study of NUV-422 for the treatment of adult patients with recurrent glioblastoma, malignant gliomas, hormone receptor-positive breast cancer and metastatic castration-resistant prostate cancer. We remain on track to report top-line data from the Phase 1 portion of the study in 2022," said David Hung, M.D., founder and chief executive officer of Nuvation Bio. "Additionally, we remain well capitalized to advance our full pipeline of novel oncology therapeutic candidates for difficult-to-treat cancers and look forward to providing clinical development updates."

Recent Business Highlights

Enrollment ongoing in Phase 1/2 multiple expansion cohort study of NUV-422. During the third quarter of 2021, Nuvation Bio continued to enroll patients in the Phase 1/2 study of NUV-422, a CDK 2/4/6 inhibitor. The Company submitted a protocol amendment to the U.S. Food and Drug Administration (FDA) in the second quarter, expanding the study to include additional cohorts for patients with recurrent glioblastoma, hormone receptor-positive metastatic breast cancer (with and without brain metastases) and metastatic castration-resistant prostate cancer. Enrollment is ongoing and data from the Phase 1 portion of the study is expected in 2022.
Second Quarter Financial Results

As of September 30, 2021, Nuvation Bio had cash, cash equivalents and marketable securities of $791.8 million.

For the three months ended September 30, 2021, research and development expenses were $17.1 million, compared to $8.6 million for the three months ended September 30, 2020. The increase was primarily due to a $5.3 million increase in third-party costs related to research services and manufacturing to advance our current preclinical programs and Phase 1/2 clinical trial, as well as a $3.2 million increase in personnel-related costs driven by an increase in headcount and stock-based compensation.

For the three months ended September 30, 2021, general and administrative expenses were $5.7 million, compared to $2.9 million for the three months ended September 30, 2020. The increase was primarily due to a $1.9 million increase in personnel-related costs driven by an increase in headcount and stock-based compensation, a $1.1 million increase in insurance, a $0.3 million increase in other miscellaneous expenses offset by a $0.4 million decrease in professional fees and a $0.1 million decrease in legal fees.

For the three months ended September 30, 2021, Nuvation Bio reported a net loss of $22.0 million, or $(0.11) per share. This compares to a net loss of $11.0 million, or $(0.12) per share, for the comparable period in 2020.

On November 10, 2021 atrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, reported its third quarter 2021 financial results and provides a business update (Press release, Pulmatrix, NOV 10, 2021, View Source [SID1234595147]).

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"The resolution of our contract dispute with Cipla is an important milestone which will enable the continued development of Pulmazole globally with our valued partners," said Ted Raad, Chief Executive Officer of Pulmatrix. "After our successful FDA Type C Meeting in February, we are excited to resume clinical activities with Pulmazole which has the potential to address the underlying cause of ABPA while avoiding the side effects of oral antifungals and prolonged steroid treatment. In parallel, we are making steady progress across our pipeline with top-line data expected in Q1 2022 from our fully enrolled PUR1800 Phase 1b study and we expect the initiation of a PUR3100 Phase 1study in Q2 2022."

Third Quarter and Recent Highlights:

Pulmazole

On November 8, 2021, we entered into an amendment (the "Amendment") to our development and commercialization agreement with Cipla (the "Cipla Agreement"), which modifies certain provisions of the Cipla Agreement and resolves the current dispute between us and Cipla regarding each party’s respective performance of the Cipla Agreement. Cipla will continue to share 50% of all third-party costs for the development of Pulmazole and will share 40% of our personnel, consulting and overhead costs and will reimburse us for another 10% of such costs upon the timely achievement of development milestones.
As part of the resolution, the Cipla Agreement was amended to grant Cipla exclusive rights to Cipla territories (India, South Africa, Sri Lanka, Nepal, Iran, Yemen, Myanmar and Algeria) in exchange for 2% royalties under certain circumstances. For the Cipla territories, Cipla will be initiating a clinical program and potential commercialization at its own expense. The rest of the global rights will maintain the equal cost sharing related do development and commercialization costs and equal share of free cash flow from future sales of Pulmazole.
Pulmatrix has successfully completed a Type C Meeting with the U.S. Food and Drug Administration (FDA) for the further clinical development of Pulmazole and based on feedback from the Type C Meeting, intends to initiate a Phase 2b clinical study of Pulmazole in allergic bronchopulmonary aspergillosis (ABPA) with registration endpoints in Q1 2023 with topline data expected Q2 2024 which may enable a Phase 3 registration study.
PUR3100

We plan to request a Type C meeting with the FDA to further clarify some of the responses in relation to the overall nonclinical and clinical program. We expect to submit the IND in Q1 2022 and initiate the Phase 1 study in Q2 2022 with top line data expected in Q3 2022. Following the Phase 1 study, we plan to conduct a randomized placebo-controlled Phase 2 study in patients with migraine to assess the safety and effectiveness of 2 PUR3100 doses, in which the selection of the 2 doses has been informed by the initial clinical study. We anticipate that this Phase 2 study will initiate in Q4 2022 and complete in mid 2023.

PUR1800

Enrollment is complete in the ongoing Phase 1b clinical study of PUR1800 in acute exacerbations in COPD (AECOPD). Study endpoints include safety, tolerability, and exploratory biomarkers to demonstrate target engagement and anti-inflammatory effect.
PUR1800 Phase 1b top-line data is expected in Q1 2022.
Financials

As of September 30, 2021, Pulmatrix had $53.5 million in cash and cash equivalents, compared to $31.7 million for the year ended December 31, 2020.

Revenue for the third quarter of 2021 was $1.1 million, compared to $4.4 million for the same period in 2020. The revenue for the third quarter of 2021 was the result of the collaboration and licensing agreements with JJEI.

Research and development expense was $4.0 million in the third quarter of 2021 compared to $3.9 million for the same period in 2020. The increase year–over-year was primarily attributable to increased preclinical and manufacturing costs related to the PUR3100 project partially offset by decreased spend on the PUR1800 program and the Pulmazole Ph2 clinical trial.

General and administrative expense was $1.7 million for the third quarter of 2021 compared to $1.8 million for the same period in 2020. The decrease year–over-year was primarily attributable to decreased employment costs partially offset by increased legal expense.

Net loss was $8.2 million for the third quarter of 2021 compared to a net loss of $10.6 million for the same period of 2020. The $2.4 million decrease in net loss year-over-year resulted from a one- time warrant inducement charge of $9.3 million in 2020 which was partially offset by $3.6 million and $3.3 million that resulted from a goodwill impairment charge and fluctuation in revenue recognition, respectively, in 2021.

On November 10, 2021 Palatin Technologies, Inc. (NYSE American: PTN) reported that it will announce its first quarter, fiscal year 2022 operating results on Monday, November 15, 2021, before the open of the U.S. financial markets (Press release, Palatin Technologies, NOV 10, 2021, View Source [SID1234595146]).

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Palatin will also conduct a conference call and live audio webcast hosted by its executive management team on November 15, 2021, at 9:30 a.m. ET. The conference call will include a review of the company’s operating results and an update on programs under development.

Schedule for the Operating Results Press Release, Conference Call / Audio Webcast

The audio webcast and replay can be accessed by logging on to the "Investors-Webcasts" section of Palatin’s website at View Source

On November 10, 2021 Mirati Therapeutics, Inc. (Nasdaq: MRTX), a clinical-stage targeted oncology company, reported the pricing of an underwritten public offering of 3,448,275 shares of its common stock at a price to the public of $145.00 per share (Press release, Mirati, NOV 10, 2021, View Source [SID1234595145]). The aggregate gross proceeds to Mirati from this offering are expected to be approximately $500.0 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Mirati. The offering is expected to close on or about November 15, 2021, subject to customary closing conditions. Mirati has also granted the underwriters a 30-day option to purchase up to an additional 517,241 shares of common stock in connection with the public offering.

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Mirati expects to use the net proceeds from this offering for preparing for the potential U.S. commercial launch of adagrasib in patients with KRAS G12C-mutated advanced non-small cell lung cancer, continued commercial development and manufacturing scale-up of adagrasib, on-going clinical development of adagrasib and sitravatinib, the preclinical and clinical development of MRTX1719 and MRTX1133, the development of other preclinical programs and the expansion of its organizational capabilities, and for working capital.

Goldman Sachs & Co. LLC, SVB Leerink LLC, and Cowen and Company, LLC are acting as book-running managers in the offering.

The shares of common stock described above are being offered pursuant to a shelf registration statement filed by Mirati with the Securities and Exchange Commission ("SEC") that became automatically effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected]; or from SVB Leerink LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or from Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (833) 297-2926, 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 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.

On November 10, 2021 Lennham Pharmaceuticals, a privately-held company focused on the creative use of deuterium chemistry to improve the metabolic and pharmacological profile of existing compounds, reported the discovery and patenting of its next generation testosterone candidate, d3-testosterone (Press release, Lennham Pharmaceuticals, NOV 10, 2021, View Source [SID1234595144]).

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The U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for broad patent claims covering the use of d3-testosterone. Once issued, the patent will expire in 2041.

The allowed claims cover a method of treating male hypogonadism with d3-testosterone. Lennham’s patent disclosure covers numerous additional applications for d3-testosterone, including as a treatment for breast cancer, female sexual disorders, and as a gender affirming hormone therapy.

In non-clinical studies, d3-testosterone strongly resisted metabolism to the estrogen estradiol when compared to testosterone. Lennham’s non-clinical studies also demonstrated that d3-testosterone has similar androgen receptor agonist activity as testosterone. Lennham intends to present or publish data concerning d3-testosterone at upcoming scientific forums.

"Testosterone has demonstrated significant clinical benefit in treating a variety of conditions including breast cancer, female sexual dysfunction, male hypogonadism, and as gender affirming hormone therapy, but its therapeutic use has been limited in part because of estrogen-related side effects," said Bradford C. Sippy, Founder and CEO of Lennham. "Based on our preclinical studies and the scientific literature, we believe that d3-testosterone, by addressing estrogen-related limitations, has the potential to unlock the full therapeutic utility of testosterone therapy and become a best-in-class hormone treatment."

About Testosterone

Testosterone is a naturally occurring hormone that is found in both men and women. Products containing testosterone and prodrugs of testosterone, such as testosterone undecanoate, have been approved for use by FDA to treat certain conditions such as male hypogonadism and delayed puberty.

Testosterone is metabolized in humans to estradiol, 5α-dihydrotestosterone (DHT), and other hormones. The conversion of testosterone to estradiol, the primary estrogen metabolized from testosterone and the most prevalent estrogen in humans, is linked to several side effects of testosterone therapies, such as gynecomastia. It is reported that 30% of men using a testosterone therapy also use an aromatase inhibitor or and selective estrogen receptor modulator, products indicated to treat breast cancer, to reduce or treat symptoms of hyperestrogenism.1

Testosterone has been identified as a potentially useful treatment in other diseases and conditions, such as breast cancer2 and female sexual disorders3, but concerns about estradiol-related side effects such as breast cancer have limited its therapeutic potential4,5,6.

About Deuterated Testosterone

Deuterium is a naturally occurring, stable isotope of hydrogen, with an additional neutron in its nucleus. Selectively substituting hydrogen with deuterium, or deuteration, is a way to alter a molecule’s metabolic profile while maintaining its core pharmacodynamic characteristics.

Deuteration strengthens the chemical bond between two elements. Depending on where deuterium is placed, it has the potential to alter the overall metabolism of a molecule, or to reduce conversion to specific, unwanted metabolites.

Deuteration has been successfully leveraged in several approved and/or late-stage pharmaceutical products.

In non-clinical studies, d3-testosterone was shown to be highly resistant to metabolism to estradiol, potentially resulting in improved safety and tolerability profile versus testosterone.

Lennham’s allowed patent claims cover a method of treating hypogonadism in a male subject by orally, parenterally, or transdermally administering to the subject a pharmaceutical composition comprising between 1 mg and 1,000 mg of d3-testosterone, or a related prodrug.