On November 7, 2022 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results and operational updates for the quarter ended September 30, 2022 (Press release, ORIC Pharmaceuticals, NOV 7, 2022, View Source [SID1234623338]).

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"We are pleased with the steady enrollment progress across our three ongoing Phase 1b studies and are looking forward to sharing initial clinical data for ORIC-533, ORIC-114 and ORIC-944 in the first half of 2023. Building on the strong enrollment in South Korea for ORIC-114, our brain penetrant EGFR/HER2 exon 20 program, we accelerated plans for the US IND filing and received clearance from the FDA during the third quarter," said Jacob M. Chacko, MD, chief executive officer. "We continue to be encouraged by data demonstrating ORIC-533, our oral small molecule inhibitor of CD73, has therapeutic potential in multiple myeloma and look forward to the presentation of ORIC-533 preclinical data at the 2022 ASH (Free ASH Whitepaper) Annual Meeting next month."

Third Quarter 2022 and Other Recent Highlights

ORIC-114 US IND Filing and FDA Clearance: ORIC continued to expand the clinical development of ORIC-114 by submitting and receiving clearance from the FDA of its US IND application in the third quarter of 2022. A Phase 1b trial with ORIC-114 as a single agent is already underway in South Korea and has been enrolling patients with advanced solid tumors with EGFR or HER2 exon 20 alterations or HER2 amplification and allows patients with CNS metastases that are either treated or untreated but asymptomatic.

ORIC-533 Preclinical Data to be Presented at the 2022 ASH (Free ASH Whitepaper) Annual Meeting: ORIC announced a preclinical poster presentation on its CD73 inhibitor in multiple myeloma will be presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held December 10-13, 2022, in New Orleans, LA.

Anticipated Program Milestones

ORIC anticipates the following upcoming milestones:

ORIC-533 (oral CD73 inhibitor): Initial Phase 1b data in 1H 2023

ORIC-114 (brain penetrant EGFR/HER2 exon 20 inhibitor): Initial Phase 1b data in 1H2023

ORIC-944 (allosteric PRC2 inhibitor): Initial Phase 1b data in 1H 2023

Third Quarter 2022 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $218.0 million as of September 30, 2022, which the company expects will fund its current operating plan into the second half of 2024.

R&D Expenses: Research and development (R&D) expenses were $14.7 million for the three months ended September 30, 2022, compared to $12.9 million for the same period in 2021. The increase was primarily driven by a net increase in external expenses related to the advancement of product candidates as well as higher personnel costs. For the nine months ended September 30, 2022, R&D expenses were $45.4 million, compared to $40.1 million for the same period of 2021. The increase was primarily driven by a net increase in external expenses related to the advancement of ORIC-533, ORIC-114, ORIC-944 and other product candidates as well as higher personnel costs, including non-cash stock-based compensation of $0.8 million.

G&A Expenses: General and administrative (G&A) expenses were $6.0 million for the three months ended September 30, 2022, compared to $5.6 million for the same period in 2021. The increase was primarily due to higher personnel costs. For the nine months ended September 30, 2022, G&A expenses were $19.3 million compared to $16.0 million for the same period of 2021. The increase was primarily due to higher personnel costs, including additional non-cash stock-based compensation of $1.1 million.

IPR&D Expenses: In-process research and development (IPR&D) expense of $5.0 million for the three and nine months ended September 30, 2022, was due to a development milestone payment made to Voronoi related to ORIC-114. There were no similar costs in 2021.

On November 7, 2022 Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported third quarter 2022 financial results and business highlights (Press release, Biomea Fusion, NOV 7, 2022, View Source [SID1234623337]).

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"We continue to solidify Biomea’s position as the leader in next-generation covalent medicines, and build near- and long-term value, through our rapid progress and strong execution. With BMF-219, we have now brought the first covalent menin inhibitor to the clinic for KRAS-mutated solid tumors, adding to our already robust development strategy of BMF-219 in distinct patient subsets of multiple liquid tumors. In addition, we are very excited to announce the first type 2 diabetes patient dosed with BMF-219, which marks the first non-oncology indication for which an investigational menin inhibitor is being evaluated in the clinic," said Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board. "Over the coming quarters, we expect to gain valuable feedback and believe we will achieve clinical proof of concept for BMF-219 in multiple indications. We also continue to advance our second IND candidate, BMF-500, an investigational covalent FLT3 inhibitor with best-in-class potential, toward the clinic. BMF-500 further demonstrates the versatility enabled by our proprietary FUSION System to discover and validate novel covalent product candidates."

Third Quarter 2022 and Recent Pipeline Highlights

Oncology

COVALENT-101
Continued site activation and patient enrollment across four liquid tumor cohorts including patients with AML/ALL (including those with MLL rearrangement and NPM1 mutation), DLBCL, MM and CLL
Cohort I (AML/ALL with MLL-r or NPM1) is enrolling patients in the escalation phase currently at Dosing Level #3. No DLTs observed, enrollment is proceeding on track for near term expansion and initial data in the first half of 2023
Cohort IV (CLL) achieved its first patient enrolled in October 2022
COVALENT-102
Received FDA clearance in October 2022 and initiated a Phase I/Ib clinical trial of BMF-219 as a monotherapy in patients who have unresectable, locally advanced, or metastatic NSCLC, CRC or PDAC with any (pan) KRAS mutation
Preclinical
Presented abstract "Anti-tumor activity of covalent menin inhibitor, BMF-219, in High-Grade B-Cell Lymphoma and Multiple Myeloma Preclinical Models" at the 2022 International Myeloma Society (IMS) Annual Meeting in Los Angeles, CA
Announced abstract "BMF-500: An Orally Bioavailable Covalent Inhibitor of FLT3 with High Selectivity and Potent Antileukemic Activity in FLT3-Mutated AML" to be presented at the 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in New Orleans, LA
Diabetes

COVALENT-111
Initiated COVALENT-111 a multi-site, double-blind, randomized, placebo-controlled Phase I/II study of BMF-219 following clearance of CTA by Health Canada; alignment has been reached with the FDA on the contents of the IND filing
Completed the healthy volunteer portion in Phase I/II (COVALENT-111) study of BMF-219 currently ongoing in Canada. No safety signals were detected
Dosed first type 2 diabetes patient in Phase I/II (COVALENT-111) study of BMF-219 currently ongoing in Canada
Preclinical
Presented two oral abstracts, "Oral Menin Inhibitor, BMF-219, displays a significant and durable reduction in HbA1c in a Type 2 Diabetes Rat Model" and "Oral Long-Acting Menin Inhibitor, BMF-219, Normalizes Type 2 Diabetes Mellitus in Two Rat Models" at the 2022 European Association for the Study of Diabetes (EASD) Annual Meeting in Stockholm, Sweden
New preclinical data from two in-vivo models at EASD demonstrated BMF-219’s ability to improve pancreatic beta cell mass and function, and BMF-219’s robust and prolonged glycemic control, insulin sensitization, and reduction of weight and lipid levels
Outlook

Submit IND for BMF-219 in type 2 diabetes patients before the end of 2022
Present clinical update of AML/ALL patients (including those with MLL rearrangement and NPM1 mutation), dosed in COVALENT-101 study in the first half of 2023
Present clinical update on type 2 diabetes patients in the first half of 2023
Submit IND for BMF-500 in patients with FLT3 mutations in the first half of 2023
Present clinical update of the healthy volunteer section of our Phase I/II type 2 diabetes COVALENT-111 study of BMF-219 at a scientific meeting in 2023
Expect to provide an update leveraging the proprietary FUSIONTM System, a discovery and design platform to expand pipeline of covalent medicines for cancer to a third development candidate in the first half of 2023
Third Quarter 2022 Financial Results

Cash, Cash Equivalents, Restricted Cash, and Investments: As of September 30, 2022, the Company had cash, cash equivalents, restricted cash, and investments of $133.8 million, compared to $175.7 million as of December 31, 2021.
Net Income/Loss: Biomea reported a net loss attributable to common stockholders of $22.9 million for the three months ended September 30, 2022, compared to a net loss of $12.6 million for the same period in 2021. Net loss attributable to common stockholders was $56.5 million for the nine months ended September 30, 2022, compared to a net loss of $26.9 million for the same period in 2021.
Research and Development (R&D) Expenses: R&D expenses were $18.2 million for the three months ended September 30, 2022, compared to $7.9 million for the same period in 2021. The increase of $10.4 million was primarily due to an increase in preclinical and clinical development costs as well as an increase in personnel-related expenses. R&D expenses were $42.2 million for the nine months ended September 30, 2022, compared to $16.9 million for the same period in 2021. The increase of $25.3 million was primarily due to an increase in personnel-related expenses, as well as an increase in preclinical and clinical development costs, including manufacturing and external consulting, related to the Company’s product candidates, BMF-219 and BMF-500.
General and Administrative (G&A) Expenses: G&A expenses were $5.2 million for the three months ended September 30, 2022, compared to $4.8 million for the same period in 2021. The increase of $0.5 million was primarily due to higher personnel-related expenses and other corporate costs to support the Company’s expanding operations as well as additional costs incurred as a public company. G&A expenses were $15.2 million for the nine months ended September 30, 2022, compared to $10.0 million for the same period in 2021. The increase of $5.2 million was primarily due to higher personnel-related expenses and other corporate costs to support the Company’s expanding operations as well as additional costs incurred as a public company.

On November 7, 2022 Inhibrx, Inc. (Nasdaq: INBX), a biopharmaceutical company with four clinical programs in development and a strong emerging pipeline, reported financial results for the third quarter of 2022 and provided an update on recent corporate highlights (Press release, Inhibrx, NOV 7, 2022, View Source [SID1234623336]).

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Recent Corporate Highlights

On August 15, 2022, Inhibrx announced that the European Commission, based on a positive opinion issued by the European Medicines Agency, has granted orphan medicinal product designation to INBRX-109 for the treatment of chondrosarcoma.
On October 4, 2022, Inhibrx announced that, based on discussions with the U.S. Food and Drug Administration (FDA), there is potential to pursue an accelerated approval in the United States for INBRX-101 in patients with emphysema due to Alpha-1 Antitrypsin Deficiency (AATD) using functional alpha-1 antitrypsin (AAT) serum levels as the surrogate endpoint. Inhibrx plans to initiate in the first quarter of 2023 a potential registration-enabling clinical trial using functional AAT as a surrogate endpoint with the intent to submit for regulatory approval under the FDA’s Accelerated Approval Program.
On October 4, 2022, Inhibrx announced the detection of INBRX-101 in the bronchoalveolar lavage fluid samples from all AATD patients tested in the Phase 1 study.
On October 26, 2022, Inhibrx announced the draw of its final tranche under its loan and security agreement with Oxford Finance LLC and received gross proceeds of $30.0 million.
Financial Results

Cash and Cash Equivalents. As of September 30, 2022, Inhibrx had cash and cash equivalents of $146.1 million, compared to $131.3 million as of December 31, 2021. As of October 31, 2022, Inhibrx had cash and cash equivalents of $290.2 million.
R&D Expense. Research and development expenses were $24.9 million during the third quarter of 2022, compared to $18.5 million during the third quarter of 2021. During the third quarter of 2022, Inhibrx’s clinical trial expenses increased, both for its Phase 1 trials as they continue to progress, as well as its continued expenses related to the INBRX-109 potentially registration-enabling Phase 2 trial which was initiated during the second quarter of 2021. The organization also incurred increased contract manufacturing expenses due to greater production run costs at its contract development and manufacturing organization partners, including drug substance batch manufacturing in preparation for a Phase 2 trial supply and pilot batch production for one of its preclinical candidates. Personnel-related costs also increased during the period, which is attributable to an increase in headcount as Inhibrx continues to expand its clinical operations and technical operations teams.
G&A Expense. General and administrative expenses were $5.3 million during the third quarter of 2022, compared to $2.8 million during the third quarter of 2021. This overall increase was primarily driven by an increase in additional personnel-related costs due to an increase in headcount as the organization builds out its commercial strategy team. In addition, Inhibrx incurred market research and other scientific publication expenses related to its continued pre-commercialization efforts for INBRX-101 and INBRX-109.
Net Loss. Net loss was $35.3 million during the third quarter of 2022, or $0.90 per share, compared to $20.6 million during the third quarter of 2021, or $0.54 per share.
About the Inhibrx sdAb Platform
Inhibrx utilizes diverse methods of protein engineering in the construction of therapeutic candidates that can address the specific requirements of complex target and disease biology. A key tool for this effort is the Inhibrx proprietary single-domain antibody (sdAb) platform, which enables the development of therapeutic candidates with attributes superior to other monoclonal antibody and fusion protein approaches. This platform allows the combination of multiple binding units in a single molecule, enabling the creation of therapeutic candidates with defined valency or multiple specificities that can achieve enhanced cell signaling or conditional activation. An additional benefit of this platform is that these optimized, multi-functional entities can be manufactured using the established processes that are commonly used to produce therapeutic proteins.

On November 7, 2022 FibroGen, Inc. (NASDAQ: FGEN) reported a royalty monetization financing with NovaQuest Capital Management (NovaQuest) that will result in proceeds to FibroGen in the amount of $50 million, bringing non-dilutive capital to drive innovation and growth (Press release, FibroGen, NOV 7, 2022, View Source [SID1234623335]).

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NovaQuest is a strategic financial partner that is aligned with the company’s growth ambitions and demonstrates confidence in the anticipated commercial opportunity and launch performance of EVRENZO. The financing provides capital to expand and advance the company’s wholly-owned late-stage pipeline toward commercialization.

"This transaction reflects the meaningful value roxadustat can generate in the territories partnered with Astellas, and FibroGen’s ability to execute a non-dilutive transaction to strengthen our balance sheet," said Enrique Conterno, Chief Executive Officer, FibroGen. "Part of the proceeds will be used to further fund our wholly-owned pamrevlumab program, as we anticipate multiple pivotal Phase 3 readouts in 2023 and 2024. Executing this deal in the current market environment speaks to the quality of the assets and the aligned confidence in the commercial opportunity of EVRENZO by NovaQuest Capital Management."

The deal includes the following terms:

$50 million cash upfront in exchange for 22.5% of future EVRENZO royalties in the territories partnered with Astellas – Japan, Europe, and certain other territories.
The aggregate payments to be received by NovaQuest Capital under this Agreement are capped at certain fixed multiples of the upfront payment based upon time. Once NovaQuest receives an aggregate of either:
$100 million (2.0x the upfront) by the end of 2028, or
$112.5 million (2.25x the upfront) by the end of 2029, or
$125 million (2.50x the upfront) by the end of 2030,
the Agreement will expire resulting in FibroGen retaining all subsequent EVRENZO royalties.

"NovaQuest is excited to utilize its differentiated Product Finance solution and support FibroGen in creating innovative, first-in-class medicines for chronic and life-threatening conditions by leveraging patients’ natural pathways," said Ryan Wooten, Managing Director at NovaQuest. "We look forward to FibroGen continuing to execute on their pipeline and delivering new therapeutics to the global patient community."

Morgan Stanley & Co. LLC acted as the sole structuring agent and Goodwin Procter LLP acted as counsel to FibroGen. Wyrick Robbins Yates & Ponton LLP acted as counsel to the investor.

On November 7, 2022 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported that it will release its financial results for the third quarter 2022 and provide a business update on Monday, November 14, 2022 (Press release, Protalix, NOV 7, 2022, View Source [SID1234623322]).

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Management will host a conference call with investors to discuss the financial results and provide an update on recent corporate and regulatory developments.

The conference will be webcast live from the Company’s website and will be available via the following links:

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.