On November 8, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported the financial results and corporate updates for the first nine months 2022 (Press release, Evotec, NOV 8, 2022, View Source [SID1234623522]).

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HIGHLIGHTS
EVOTEC’S TOPLINE SUCCESS REFLECTS STRONG OVERALL DEMAND
Group revenues increased by 19% (13% excluding fx-effects) to € 510.8 m (9M 2021: € 431.0 m), despite significantly lower milestones, upfronts and license payments compared to a very strong comparable basis in 2021 (9M 2022: € 8.1 m vs. € 36.5 m in 9M 2021); base business at € 502.7 m continued to show very strong growth of 27% (9M 2021: € 394.5 m).
Strong progress in both segments: Total EVT Execute revenues (incl. intersegment revenues) up 23% to € 526.7 m (9M 2021: € 429.8 m); EVT Innovate revenues up 20% to € 121.9 m (9M 2021: € 101.9 m), against a very high comparable basis.
Other non-operating result of € (119.6) m (9M 2021: € 228.8 m), mainly driven by the non-cash fair value adjustments of the equity investment in publicly listed Exscientia plc.
Adjusted Group EBITDA totalled € 44.6 m (9M 2021: € 70.1 m); influenced by high expenses for capacity expansion to support the overall growth of Evotec, significantly inflated energy costs as well as lower contribution from milestones, upfronts and licenses, partially offset by positive fx-effects (€ 12.4 m); Just – Evotec Biologics is in its planned ramp up phase; Adjusted EBITDA excluding Just – Evotec Biologics at € 84.6 m (9M 2021: € 74.0 m).

SHARED R&D PLATFORMS FOR HIGHER PROBABILITIES OF SUCCESS (POS)
Multiple new and extended integrated drug discovery and development agreements all along the drug discovery & development value chain (e.g., integrated drug discovery agreement with Viotika, commercial manufacturing with Zogenix, ADME Tox agreements with UCB …)
Successful achievement of four performance-based milestones within existing partnerships; one IND submission, one preclinical development candidate nomination and one lead optimisation start
Significant progress within neuroscience collaboration with Bristol Myers Squibb ("BMS")
Expansion of E.MPD molecular patient database into autoimmune diseases through partnership with Hannover Medical School ("MHH") (after period-end)
Paradigm shift in biologics with Just – Evotec Biologics: Foundation laid for accelerated revenue growth through multiple new development and manufacturing agreements, e.g., with Alpine Immune Sciences; ground-breaking for second new biologics facility J.POD Toulouse, France, on 16 September
J.POD Redmond, Washington (US) joined the U.S. Department of Defense’s ("DOD") Advanced Development and Manufacturing network of facilities and wins a first contract worth up to $ 49.9 m; second award with the U.S. Department of Defense ("DOD") granted after period end.
Commercial launch of proprietary next-generation multi-omics data analysis platform PanHunter (after period-end).
Expansion of BRIDGE LAB150 to include Amgen as a strategic partner (after period-end)

CORPORATE
Expansion of clinical and commercial drug substance manufacturing capacities through acquisition of Central Glass Germany, operating as Evotec Drug Substance (Germany) GmbH ("Evotec DS").

BUSINESS OUTLOOK FOR FULL-YEAR 2022 UNCHANGED AND MID-TERM TARGETS 2025 CONFIRMED
Group revenues expected to be in a range of € 715 – 735 m or € 690 – 710 m at constant exchange rates (2021: € 618 m).
Adjusted Group EBITDA expected to be unchanged in the range of € 105 – 120 m, translating into € 85 – 100 m at constant exchange rates (2021: € 107 m).
Unpartnered research and development expenses expected to be in a range of € 70 – 80 m (2021: € 58 m).
Mid-term goals target revenue growth to > € 1,000 m, adjusted EBITDA of ≥ € 300 m and unpartnered research and development expenses of > € 100 m.

The forecast takes in account – as far as possible – the current increased global uncertainties related to e.g., the COVID-19 pandemic and the war in Ukraine, resulting in uncertainty around the global price and supply situation for energy, other raw materials and supplies as well as logistics relevant to the business. M&A related costs have not been part of the initial guidance and will therefore be excluded.

More detailed information and financial tables are available in our nine-month report published on the Evotec website under the following link: View Source

WEBCAST / CONFERENCE CALL
The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

You will then receive a confirmation email with dedicated dial-in details such as telephone number, access code and PIN to access the call.

A simultaneous slide presentation for participants dialling in via phone is available at View Source

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our homepage shortly before the event.

The on-demand version of the webcast will be available on our website: View Source.

On November 8, 2022 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the third quarter ended September 30, 2022, and recent corporate highlights (Press release, Checkpoint Therapeutics, NOV 8, 2022, View Source [SID1234623521]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "In the third quarter of 2022, we successfully completed two pre-Biologics License Application ("BLA") meetings with the U.S. Food and Drug Administration ("FDA"). Importantly, we continue to achieve significant progress toward our planned submission of a BLA by January of next year, which will include both the metastatic and locally advanced cutaneous squamous cell carcinoma ("cSCC") indications. We believe cosibelimab, with its differentiated two-fold mechanism of action, has the potential to be the first anti-PD-L1 antibody approved for advanced cSCC, which is the second most frequently diagnosed skin cancer, and provide physicians worldwide with an important new treatment option in the fight against this common and possibly deadly cancer. Our planned BLA submission will represent a significant milestone both for us as a company and for patients seeking treatment for cSCC."

"The reverse stock split recently approved by shareholders and planned for December is a proactive measure that we are confident will improve long-term liquidity and better position us for success by providing the opportunity for our stock to trade in a price range more attractive to a broader array of institutional investors. This increased visibility with institutional investors is critical as we continue our transition from a development-stage company to a fully integrated commercial organization to support the potential launch of cosibelimab."

Recent Corporate Highlights:

·In July 2022, Checkpoint successfully completed two pre-BLA meetings with the FDA (chemistry, manufacturing and controls [CMC] and clinical/non-clinical). Based upon favorable interactions with the agency, the planned BLA submission will include both the metastatic and locally advanced cutaneous squamous cell carcinoma indications. Checkpoint also reached agreement with the FDA on all key aspects discussed with regard to the content of the upcoming BLA submission.
·In November 2022, holders of a majority of the voting power of the capital stock of Checkpoint approved a 1-for-10 reverse stock split of the company’s common stock. Checkpoint expects its common shares will begin trading on a split-adjusted basis on the Nasdaq Capital Market in December 2022. The Board of Directors determined the 1-for-10 ratio to be appropriate in order to improve the marketability and liquidity of Checkpoint’s common stock and to remain in compliance with all of Nasdaq’s continued listing requirements.

Financial Results:

·Cash Position: As of September 30, 2022, Checkpoint’s cash and cash equivalents totaled $20.5 million, compared to $30.9 million at June 30, 2022 and $54.7 million at December 31, 2021, a decrease of $10.4 million for the quarter and a decrease of $34.2 million for the first nine months of 2022.
·R&D Expenses: Research and development expenses for the third quarter of 2022 were $8.9 million, compared to $9.4 million for the third quarter of 2021, a decrease of $0.5 million. Research and development expenses for the third quarter of 2022 included $0.3 million of non-cash stock expenses, compared to $0.2 million for the third quarter of 2021.
·G&A Expenses: General and administrative expenses for the third quarter of 2022 were $1.8 million, compared to $1.9 million for the third quarter of 2021, a decrease of $0.1 million. General and administrative expenses for the third quarter of 2022 included $0.5 million of non-cash stock expenses, compared to $0.6 million for the third quarter of 2021.
·Net Loss: Net loss attributable to common stockholders for the third quarter of 2022 was $10.6 million, or $0.12 per share, compared to a net loss of $11.3 million, or $0.14 per share, in the third quarter of 2021. Net loss for the third quarters of 2022 and 2021 both included $0.8 million of non-cash stock expenses.

On November 8, 2022 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, reported that its product portfolio of FDA-approved brands delivered combined revenues of $11.4 million during the third quarter of 2022 – a 41% increase over the prior year period (Press release, Cumberland Pharmaceuticals, NOV 8, 2022, View Source [SID1234623520]). Cumberland also reported a 19% increase in net revenues for the first nine months of the year compared to the same period in 2021.

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The Company ended the third quarter with $91 million in total assets, $53 million in total liabilities, and $38 million of shareholders’ equity.
"Fueled by initial sales from our newest product Sancuso, we saw tremendous growth during the third quarter and the first nine months of 2022," said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. "As we move through the final quarter of the year, we look forward to building on this success. As always, we remain sharply focused on our mission of improving patient care through the delivery of high-quality medicines."
QUARTER HIGHLIGHTS:
Sancuso Acquisition and Transition
Following its acquisition of Sancuso from Kyowa Kirin, Inc. in January, Cumberland largely completed the transition of the product, assuming responsibilities for its sales, distribution and promotion in the U.S. Sancuso is an FDA-approved prescription patch that prevents nausea and vomiting in patients undergoing certain types of chemotherapy.
Sancuso Promotion
Cumberland formed a new sales division, Cumberland Oncology, to support Sancuso and also entered into an agreement with Verity Pharmaceuticals International Limited for the national co-promotion of the brand.
Under the terms of the agreement, Verity will utilize its established oncology commercial organization to co-promote Sancuso throughout the U.S. Verity completed the training and launched its sales efforts in support of Sancuso during the third quarter of 2022.
RediTrex Agreement with Nordic Pharma
In July 2022, Cumberland entered into an amendment to its agreement with Nordic Pharma addressing the responsibilities and financial arrangements regarding Cumberland’s license to Nordic’s methotrexate line of products for the U.S., which are marketed under the brand name RediTrex.
Based on the amendment, Nordic has the opportunity to assume responsibility for commercializing the methotrexate products in the U.S. after March 31, 2023. Until then, Cumberland will continue to distribute

and support the RediTrex product line. Following the return of the license, Nordic will provide Cumberland with a royalty on their future sales of the product through April 2035.
New Headquarter Office Location
In October 2022, Cumberland relocated its headquarters to the Broadwest campus in the Vanderbilt/West End corridor of Nashville. The new, state-of-the-art headquarters keeps the company close to Vanderbilt University Medical Center, enabling their continued collaboration as Cumberland works to develop new medicines for the future.
The move also allows Cumberland to accommodate recent and future growth. Following the relocation, Cumberland expects to expand its organization to over 100 individuals, with a majority working from the Nashville headquarters.
Ifetroban Clinical Studies
Currently, Cumberland is sponsoring three Phase II clinical trials to evaluate its ifetroban product candidate, for patients with:
•Aspirin-Exacerbated Respiratory Disease ("AERD"), a severe form of asthma;
•Systemic Sclerosis, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs; and
•Cardiomyopathy associated with Duchenne Muscular Dystrophy, a genetic neuromuscular disease that results in deterioration of the skeletal, heart and lung muscles.
The company is also working on an application to the FDA for a fourth Phase II program, which will evaluate the use of ifetroban to treat patients with Progressive Fibrosing Interstitial Lung Diseases.
The company-sponsored AERD study has been closed to enrollment. Once quality checks on the study database are complete, analysis of the results will be conducted and top-line results will then be announced. Once the results of its other sponsored Phase II studies are available, Cumberland will decide on the best development path for the registration of ifetroban.
FINANCIAL RESULTS:
Net Revenue: For the three months ended September 30, 2022, net revenues from continuing operations were $11.4 million, a 41% increase over the prior year period.
Net revenue by product for the third quarter of 2022, included $4.0 million for Sancuso, $3.9 million for Kristalose, $1.9 million for Vibativ and $0.9 million for Caldolor.
Year-to-date 2022 net revenues were $33 million, a 19% increase compared to $28 million for the first nine months of 2021.
Year-to-date net revenues by product were $11.4 million for Kristalose, $10.8 million for Sancuso, $6.0 million for Vibativ and $3.1 million for Caldolor.
Operating Expenses: Total operating expenses for the third quarter were $11.7 million, compared to $9.6 million for the prior year period.
Year-to-date 2022 operating expenses were $36.3 million, compared to $31.0 million for 2021.
Earnings: Net loss for the third quarter of 2022 was $0.4 million, a significant improvement over the $1.1 million net loss during the prior year period.

Adjusted earnings: Adjusted earnings for the third quarter of 2022 were $1.4 million, or $0.10 per share, a significant improvement over the $0.3 million adjusted loss during the same period in 2021. The third quarter 2022 adjusted earnings calculation does not include the benefit of the $1.0 million of Vibativ cost of goods, which were received with the product acquisition. It also does not include the benefit of the $0.4 million of Sancuso cost of goods, which were received with that product’s acquisition.
Cash Flow: Year-to-date cash flow from operations was $5.6 million, a 28% increase over the $4.4 million during the prior year period.
Balance Sheet: At September 30, 2022, Cumberland had $91 million in total assets, including $20 million in cash and cash equivalents. Total liabilities were $53 million, including $18 million outstanding on the Company’s revolving line of credit. Total shareholders’ equity was $38 million.
EARNINGS REPORT CALL:
Cumberland will provide its financial results for the third quarter of 2022 via a conference call today at 4:30 p.m. Eastern Time.
To join the call, register at
https://register.vevent.com/register/BI21ae99e384c446cfb00fbab05f8bf1a3.
Registered participants can dial in from their phone using a dial-in and PIN number that will be provided. They can also choose a "Call Me" option to have the system automatically call them at the start of the conference call.
Available on Cumberland’s website for one year, a replay of the call can be accessed by visiting View Source

On November 8, 2022 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology," Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported third quarter financial results for the period ended September 30, 2022, and provided a business update (Press release, Olema Oncology, NOV 8, 2022, View Source [SID1234623517]).

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"On the heels of presenting our preliminary monotherapy dose expansion study results at ENA 2022, and with initial combination study data coming later this quarter at SABCS, we believe OP-1250 has shown itself to be a highly differentiated CERAN/SERD that completely shuts down estrogen receptor (ER) transcriptional activity in both wild-type and ESR1 mutant receptors," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We have been granted Fast Track designation from the FDA in second- and third-line ER+/HER2- metastatic breast cancer, and we are rapidly generating more data in support of initiating our first pivotal Phase 3 monotherapy study mid-next year. As we enter the next stage of development and with an evolving competitive landscape, we are driven to continue our mission to improve outcomes for women living with cancer."

Recent Corporate Highlights

●Presented preliminary clinical results from a Phase 1/2 clinical study of OP-1250 at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (ENA 2022) in Barcelona, Spain.
●Study results demonstrated that across 68 heavily pre-treated patients at 60 mg and 120 mg once daily oral doses, OP-1250 was well tolerated with attractive pharmacokinetics (PK) and sustained drug exposure levels approximately 20 times that of fulvestrant at the 120 mg dose. In addition, OP-1250 demonstrated strong anti-tumor activity, with 41% of patients seeing reductions in target tumor lesions, and durable benefit. Six partial responses (four confirmed and two unconfirmed) were observed in 57 efficacy-evaluable patients.
●Following the selection of RP2D based on pharmacokinetics, safety and tolerability, and encouraging early anti-tumor activity, the Phase 2 monotherapy study is rapidly advancing with primary cohorts fully enrolled: patients with measurable disease (N=50) and patients with non-measurable disease (N=15).
●Dose escalation in the Phase 1b combination study with the CDK4/6 inhibitor palbociclib has completed, with Phase 2 dose expansion at 120 mg of OP-1250 in combination with palbociclib now
ongoing. Combinability has been demonstrated across the completed dose escalation cohorts (30 mg, 60 mg, 90 mg, and 120 mg of OP-1250), including no dose limiting toxicities, no change in exposure of palbociclib or OP-1250, and overall tolerability consistent with the expected profile of palbociclib plus an endocrine therapy.
●Initiated Phase 1b combination study with CDK 4/6 inhibitor, ribociclib, and phosphoinositide 3-kinase alpha (PI3Ka) inhibitor, alpelisib.
Anticipated Milestones

●Present preliminary Phase 1b dose escalation study data in combination with CDK4/6 inhibitor, palbociclib, at the 2022 San Antonio Breast Cancer Symposium in December.
●Continue combination studies with CDK4/6 inhibitors, palbociclib and ribociclib, and PI3Ka inhibitor, alpelisib.
●Present additional monotherapy and combination therapy data in 2023.
●Initiate pivotal Phase 3 monotherapy study in the second/third-line ER+/HER2- advanced or metastatic breast cancer in mid-2023.
Financial Results

●Cash, cash equivalents and marketable securities as of September 30, 2022, were $222.6 million. Olema anticipates that this balance will be sufficient to fund operations into the second half of 2024.
●Net loss for the quarter ended September 30, 2022, was $22.7 million, compared to $17.7 million for the same period of the prior year. The increase in net loss related primarily to Olema’s continued investment in OP-1250, increased spending on research and development activities, and an increase in general and administrative (G&A) costs.
●GAAP research and development (R&D) expenses were $17.6 million for the quarter ended September 30, 2022, compared to $12.5 million for the same period of the prior year. The increase in R&D expenses was primarily related to the advancement of the development program for OP-1250 and an increase in nonclinical research and discovery program activities. Non-GAAP R&D expenses were $14.8 million for the quarter ended September 30, 2022, excluding $2.8 million of non-cash stock-based compensation expense. Non-GAAP R&D expenses were $10.1 million for the quarter ended September 30, 2021, excluding $2.4 million of non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this news release.
●GAAP G&A expenses were $5.6 million for the quarter ended September 30, 2022, as compared to $5.2 million for the same period of the prior year. The increase in G&A expenses was primarily related to higher personnel-related expenses and other corporate costs. Non-GAAP G&A expenses were $4.1 million for the quarter ended September 30, 2022, excluding $1.5 million of non-cash stock-based compensation expense. Non-GAAP G&A expenses were $3.5 million for the quarter ended September 30, 2021, excluding $1.7 million of non-cash stock-based compensation expense.

On November 8, 2022 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology," Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported third quarter financial results for the period ended September 30, 2022, and provided a business update (Press release, Olema Oncology, NOV 8, 2022, View Source [SID1234623517]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"On the heels of presenting our preliminary monotherapy dose expansion study results at ENA 2022, and with initial combination study data coming later this quarter at SABCS, we believe OP-1250 has shown itself to be a highly differentiated CERAN/SERD that completely shuts down estrogen receptor (ER) transcriptional activity in both wild-type and ESR1 mutant receptors," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We have been granted Fast Track designation from the FDA in second- and third-line ER+/HER2- metastatic breast cancer, and we are rapidly generating more data in support of initiating our first pivotal Phase 3 monotherapy study mid-next year. As we enter the next stage of development and with an evolving competitive landscape, we are driven to continue our mission to improve outcomes for women living with cancer."

Recent Corporate Highlights

●Presented preliminary clinical results from a Phase 1/2 clinical study of OP-1250 at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (ENA 2022) in Barcelona, Spain.
●Study results demonstrated that across 68 heavily pre-treated patients at 60 mg and 120 mg once daily oral doses, OP-1250 was well tolerated with attractive pharmacokinetics (PK) and sustained drug exposure levels approximately 20 times that of fulvestrant at the 120 mg dose. In addition, OP-1250 demonstrated strong anti-tumor activity, with 41% of patients seeing reductions in target tumor lesions, and durable benefit. Six partial responses (four confirmed and two unconfirmed) were observed in 57 efficacy-evaluable patients.
●Following the selection of RP2D based on pharmacokinetics, safety and tolerability, and encouraging early anti-tumor activity, the Phase 2 monotherapy study is rapidly advancing with primary cohorts fully enrolled: patients with measurable disease (N=50) and patients with non-measurable disease (N=15).
●Dose escalation in the Phase 1b combination study with the CDK4/6 inhibitor palbociclib has completed, with Phase 2 dose expansion at 120 mg of OP-1250 in combination with palbociclib now
ongoing. Combinability has been demonstrated across the completed dose escalation cohorts (30 mg, 60 mg, 90 mg, and 120 mg of OP-1250), including no dose limiting toxicities, no change in exposure of palbociclib or OP-1250, and overall tolerability consistent with the expected profile of palbociclib plus an endocrine therapy.
●Initiated Phase 1b combination study with CDK 4/6 inhibitor, ribociclib, and phosphoinositide 3-kinase alpha (PI3Ka) inhibitor, alpelisib.
Anticipated Milestones

●Present preliminary Phase 1b dose escalation study data in combination with CDK4/6 inhibitor, palbociclib, at the 2022 San Antonio Breast Cancer Symposium in December.
●Continue combination studies with CDK4/6 inhibitors, palbociclib and ribociclib, and PI3Ka inhibitor, alpelisib.
●Present additional monotherapy and combination therapy data in 2023.
●Initiate pivotal Phase 3 monotherapy study in the second/third-line ER+/HER2- advanced or metastatic breast cancer in mid-2023.
Financial Results

●Cash, cash equivalents and marketable securities as of September 30, 2022, were $222.6 million. Olema anticipates that this balance will be sufficient to fund operations into the second half of 2024.
●Net loss for the quarter ended September 30, 2022, was $22.7 million, compared to $17.7 million for the same period of the prior year. The increase in net loss related primarily to Olema’s continued investment in OP-1250, increased spending on research and development activities, and an increase in general and administrative (G&A) costs.
●GAAP research and development (R&D) expenses were $17.6 million for the quarter ended September 30, 2022, compared to $12.5 million for the same period of the prior year. The increase in R&D expenses was primarily related to the advancement of the development program for OP-1250 and an increase in nonclinical research and discovery program activities. Non-GAAP R&D expenses were $14.8 million for the quarter ended September 30, 2022, excluding $2.8 million of non-cash stock-based compensation expense. Non-GAAP R&D expenses were $10.1 million for the quarter ended September 30, 2021, excluding $2.4 million of non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this news release.
●GAAP G&A expenses were $5.6 million for the quarter ended September 30, 2022, as compared to $5.2 million for the same period of the prior year. The increase in G&A expenses was primarily related to higher personnel-related expenses and other corporate costs. Non-GAAP G&A expenses were $4.1 million for the quarter ended September 30, 2022, excluding $1.5 million of non-cash stock-based compensation expense. Non-GAAP G&A expenses were $3.5 million for the quarter ended September 30, 2021, excluding $1.7 million of non-cash stock-based compensation expense.