Market Newsdesk

• TCR² and Adaptimmune announce strategic combination to create a preeminent cell therapy company focused on treating solid tumors
  
• Following the expected Q2 2023 closing of the all-stock transaction, the combined company’s cash runway is expected to extend into 2026

CAMBRIDGE, Mass., March 23, 2023 (GLOBE NEWSWIRE) — TCR² Therapeutics Inc. (Nasdaq: TCRR) (TCR² or the Company), a clinical-stage cell therapy company with a pipeline of novel next-generation T cell therapies for patients suffering from solid tumors, today announced fourth quarter and full-year 2022 financial results and provided a corporate update.

“Focus and specialization are critical in the cell therapy space. The strategic combination with Adaptimmune and the operating benefits are highly compelling for both Adaptimmune and TCR² shareholders. Our complementary technology platforms are designed to treat solid tumors which represents a substantial market opportunity largely unaddressed by cell therapies. The combination of our two companies provides a strong foundation to commercialize curative therapies for people with cancer,” said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR² Therapeutics.

Recent Developments

• TCR² announced a strategic combination with Adaptimmune Therapeutics plc (Adaptimmune) to create a preeminent cell therapy company for solid tumors. The two companies entered into a definitive agreement under which Adaptimmune will combine with TCR² in an all-stock transaction. The transaction is expected to close in the second quarter of 2023, subject to shareholder approval and satisfaction or waiver of other closing conditions. Following the closing of the transaction, Adaptimmune shareholders will own approximately 75% and TCR² stockholders will own approximately 25% of the combined company. As a result, and following the closing of the transaction, it is anticipated that the combined company’s cash runway will extend into 2026.
• TCR² published preclinical gavo-cel data in OncoImmunology. Research showed that gavo-cel more rapidly infiltrated and eliminated mesothelin-positive tumors of various histologies while producing less pro-inflammatory cytokines than second-generation mesothelin-targeted CAR T cells.
• TCR² reprioritized its pipeline to focus on gavo-cel in ovarian cancer and second-generation programs TC-510 and TC-520. In connection with the reprioritization, TCR² reduced its workforce by approximately 40 percent.

Anticipated Milestones

gavo-cel:

• First readout from the ongoing Phase 2 portion of the gavo‑cel Phase 1/2 clinical trial in ovarian cancer in combination with checkpoint inhibitors and redosing strategies anticipated in the second half of 2023.
• Interim update, including key translational data, in patients with mesothelioma treated with gavo‑cel in combination with checkpoint inhibitors in the Phase 2 portion of the gavo-cel Phase 1/2 clinical trial before the focus was narrowed to ovarian cancer anticipated midyear 2023.
• Tumor regression has been observed in 93% of patients in the Phase 1 trial. The response rate was 29% in patients with ovarian cancer with a median progression free survival (PFS) of 5.8 months and a median overall survival (OS) of 8.1 months. The response rate in mesothelioma was 21% with a median PFS of 5.9 months and a median OS of 11.2 months.

TC-510:

• First data readout from the Phase 1 trial with TC-510 for patients with ovarian, malignant pleural mesothelioma, pancreatic, colorectal, or triple-negative breast cancer anticipated in the second half of 2023.

Financial Highlights

• Cash Position: TCR² ended the fourth quarter of 2022 with $149.2 million in cash, cash equivalents, and investments compared to $265.6 million as of December 31, 2021. Net cash used in operations was $25.0 million for the fourth quarter of 2022 compared to $23.3 million for the fourth quarter of 2021.
   
• R&D Expenses: Research and development (R&D) expenses were $25.7 million for the fourth quarter of 2022 compared to $18.8 million for the fourth quarter of 2021. The increase in R&D expenses was primarily due to increased spending on clinical programs.
   
• Impairment and Restructuring Expenses: Impairment expenses were $29.9 million for the fourth quarter of 2022 compared to $3.7 million for the fourth quarter of 2021. The impairment charges during 2022 are primarily related to the Rockville manufacturing facility which have been reclassified as held for sale as of December 31, 2022.
   
• G&A Expenses: General and administrative (G&A) expenses were $5.8 million for the fourth quarter of 2022 compared to $5.2 million for the fourth quarter of 2021. The increase in G&A expenses was primarily due to an increase in personnel costs.
   
• Net Loss: Net loss was $60.5 million for the fourth quarter of 2022 compared to $27.7 million for the fourth quarter of 2021.

About gavo-cel, TC-510, and TC-520

Our most advanced program, gavo-cel, targets tumors that express the protein mesothelin.

TC-510 is an enhanced version of gavo-cel that co-expresses a PD-1:CD28 chimeric switch receptor that the Company believes may lead to deeper responses and more durable benefit.

TC-520 is the Company’s first TRuC-T cell targeting CD-70-expressing solid and liquid tumors which incorporates IL-15 pathway enhancements designed to improve T-cell persistence. TCR² is currently advancing TC-520 to Investigational New Drug (IND) status.

About TCR² Therapeutics

TCR² Therapeutics Inc. is a clinical-stage cell therapy company developing a pipeline of novel next generation T cell therapies for patients suffering from solid tumors. The Company is focused on the discovery and development of product candidates against novel and complex targets utilizing its proprietary T cell receptor (TCR) Fusion Construct T cells (TRuC^®-T cells). The TRuC platform is designed to specifically recognize and kill cancer cells by harnessing signaling from the entire TCR, independent of human leukocyte antigens (HLA). For more information about TCR², please visit www.tcr2.com.

Forward-looking Statements

This press release contains forward-looking statements and information within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “may,” “will,” “could,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “seeks,” “endeavor,” “potential,” “continue” or the negative of such words or other similar expressions can be used to identify forward-looking statements. These forward-looking statements include, but are not limited to, express or implied statements regarding: the therapeutic potential of gavo-cel, TC-510 and TCR²’s other product candidates, including potential improvements in efficacy, safety and durability in the Phase 2 portion of the gavo-cel trial, expectations regarding future growth and prospects, future clinical development plans and anticipated timing of data updates, the development of the Company’s TRuC-T cells, including their potential characteristics, applications and clinical utility, the potential therapeutic applications of the TCR²’s TruC-T cell platform, expected cash runway of the combined company following the closing of the proposed transaction with Adaptimmune, expected cost savings related to the Company’s reduction in workforce, the benefits of the transaction with Adaptimmune and expectations regarding the timing for closing of the transaction with Adaptimmune.

The expressed or implied forward-looking statements included in this press release are only current expectations, beliefs, and predictions and are subject to a number of risks, uncertainties, assumptions and important factors, including, without limitation: uncertainties as to the timing for completion of the transaction with Adaptimmune; uncertainties as to TCR²’s and/or Adaptimmune’s ability to obtain the approval of Adaptimmune’s shareholders or TCR²’s stockholders required to consummate the transaction with Adaptimmune; the possibility that competing offers will be made by third parties; the occurrence of events that may give rise to a right of one or both of Adaptimmune and TCR² to terminate the merger agreement; the possibility that various closing conditions for the transaction with Adaptimmune may not be satisfied or waived on a timely basis or at all, including the possibility that a governmental entity may prohibit, delay, or refuse to grant approval, if required, for the consummation of the transaction with Adaptimmune (or only grant approval subject to adverse conditions or limitations); the difficulty of predicting the timing or outcome of consents or regulatory approvals or actions, if any; the possibility that the transaction with Adaptimmune may not be completed in the time frame expected by Adaptimmune and TCR², or at all; the risk that Adaptimmune and TCR² may not realize the anticipated benefits of the transaction with Adaptimmune in the time frame expected, or at all; the effects of the transaction with Adaptimmune on relationships with Adaptimmune’s or TCR²’s employees, business or collaboration partners or governmental entities; the ability to retain and hire key personnel; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the transaction with Adaptimmune; significant or unexpected costs, charges or expenses resulting from the transaction with Adaptimmune; the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, synergies, economic performance, indebtedness, financial condition and losses on the future prospects, business and management strategies for the management, expansion and growth of the combined business after the consummation of the transaction with Adaptimmune; potential negative effects related to this announcement or the consummation of the transaction with Adaptimmune on the market price of Adaptimmune’s American Depositary Shares or TCR²’s common stock and/or Adaptimmune’s or TCR²’s operating or financial results; uncertainties as to the long-term value of Adaptimmune’s American Depositary Shares (and the ordinary shares represented thereby), including the dilution caused by Adaptimmune’s issuance of additional American Depositary Shares (and the ordinary shares represented thereby) in connection with the transaction with Adaptimmune; unknown liabilities related to Adaptimmune or TCR²; the nature, cost and outcome of any litigation and other legal proceedings involving Adaptimmune, TCR² or their respective directors, including any legal proceedings related to the transaction with Adaptimmune; risks related to global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations; potential delays or failures related to research and/or development of Adaptimmune’s or TCR²’s programs or product candidates; risks related to any loss of Adaptimmune’s or TCR²’s patents or other intellectual property rights; any interruptions of the supply chain for raw materials or manufacturing for Adaptimmune or TCR²’s product candidates, the nature, timing, cost and possible success and therapeutic applications of product candidates being developed by Adaptimmune, TCR² and/or their respective collaborators or licensees; the extent to which the results from the research and development programs conducted by Adaptimmune, TCR², and/or their respective collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; uncertainty of the utilization, market acceptance, and commercial success of Adaptimmune or TCR²’s product candidates, and the impact of studies (whether conducted by Adaptimmune, TCR² or others and whether mandated or voluntary) on any of the foregoing; unexpected breaches or terminations with respect to Adaptimmune’s or TCR²’s material contracts or arrangements; risks related to competition for Adaptimmune’s or TCR²’s product candidates; Adaptimmune’s or TCR²’s ability to successfully develop or commercialize Adaptimmune’s or TCR²’s product candidates; Adaptimmune’s, TCR²’s, and their collaborators’ abilities to continue to conduct current and future developmental, preclinical and clinical programs; potential exposure to legal proceedings and investigations; risks related to changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing, development or commercialization of any of Adaptimmune’s or TCR²’s product candidates; unexpected increase in costs and expenses with respect to the proposed transaction or Adaptimmune’s or TCR²’s business or operations; and risks and uncertainties related to epidemics, pandemics or other public health crises and their impact on Adaptimmune’s and TCR²’s respective businesses, operations, supply chain, patient enrollment and retention, preclinical and clinical trials, strategy, goals and anticipated milestones, risks related to global economic conditions, including disruptions in the banking industry, and other risks set forth under the caption “Risk Factors” in TCR²’s most recent Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and its other filings with the Securities and Exchange Commission. In light of these risks, uncertainties, assumptions and important factors, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those expressed or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although TCR² believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur.

Moreover, except as required by law, neither TCR² nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. TCR² undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Media Contact:

Kathy Vincent
[email protected]

Investor Contact:
Eric Sullivan
Chief Financial Officer
[email protected]

TCR2 THERAPEUTICS INC.
UNAUDITED CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except share data)
	December 31, 2022				December 31, 2021
Assets
Current assets
Cash and cash equivalents	$	32,746			$	222,564
Investments		116,433				43,029
Prepaid expenses and other current assets		5,155				10,534
Assets held for sale		23,287				–
Total current assets		177,621				276,127
Property and equipment, net		6,166				17,075
Right-of-use assets, operating leases		22,510				28,283
Restricted cash		1,152				1,156
Other assets, non-current		787				730
Total assets	$	208,236			$	323,371
Liabilities and stockholders’ equity
Accounts payable	$	2,793			$	2,144
Accrued expenses and other current liabilities		10,823				13,094
Operating lease liabilities		21,834				3,367
Operating lease liabilities related to assets held for sale		28,611				–
Total current liabilities		64,061				18,605
Operating lease liabilities, non-current		3,316				22,996
Other liabilities		–				293
Total liabilities		67,377				41,894
Stockholders’ equity
Common stock, $0.0001 par value; 150,000,000 shares authorized; 39,203,366 and 38,496,484 shares issued and outstanding as of December 31, 2022 and December 31, 2021, respectively.		4				4
Additional paid-in capital		642,644				631,008
Accumulated other comprehensive income (loss)		(445	)			(13	)
Accumulated deficit		(501,344	)			(349,522	)
Total stockholders’ equity		140,859				281,477
Total liabilities and stockholders’ equity	$	208,236			$	323,371

TCR2 THERAPEUTICS INC.
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands, except share and per share data)
		Three Months Ended December 31,								Twelve Months Ended December 31,
		2022				2021				2022				2021
Operating expenses
Research and development		$	25,736			$	18,750			$	98,643			$	73,578
Impairments and restructuring charges			29,883				3,661				30,417				3,661
General and administrative			5,803				5,206				24,439				22,503
Total operating expenses			61,422				27,617				153,499				99,742
Loss from operations			(61,422	)			(27,617	)			(153,499	)			(99,742	)
Interest income, net			1,013				38				1,938				224
Loss before income tax expense			(60,409	)			(27,579	)			(151,561	)			(99,518	)
Income tax expense			96				160				261				289
Net loss		$	(60,505	)		$	(27,739	)		$	(151,822	)		$	(99,807	)
Per share information
Net loss per share of common stock, basic and diluted		$	(1.56	)		$	(0.72	)		$	(3.93	)		$	(2.63	)
Weighted average shares outstanding, basic and diluted			38,808,447				38,289,295				38,628,105				37,935,554

TCR2 THERAPEUTICS INC.
UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS
(amounts in thousands)
	Twelve Months Ended December 31,
	2022				2021
Operating activities
Net loss	$	(151,822	)		$	(99,807	)
Adjustments to reconcile net loss to cash used in operating activities:
Depreciation and amortization		3,046				2,827
Impairment and restructuring charges		27,450				2,960
Stock-based compensation expense		11,380				12,265
(Accretion) / Amortization on investments		(802	)			837
Deferred tax liabilities		(293	)			99
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		5,557				(2,496	)
Operating leases, net		2,680				(2,416	)
Accounts payable		1,166				(771	)
Accrued expenses and other liabilities		177				4,899
Cash used in operating activities		(101,461	)			(81,603	)
Investing activities
Purchases of equipment		(15,122	)			(11,098	)
Software development costs		(330	)			(351	)
Purchases of investments		(267,522	)			(50,726	)
Proceeds from sale or maturity of investments		194,488				140,622
Cash provided by (used in) investing activities		(88,486	)			78,447
Financing activities
Proceeds from public offering of common stock, net of issuance costs		–				131,330
Proceeds from the exercise of stock options		256				1,217
Payment of deferred offering costs		(131	)			(409	)
Cash provided by financing activities		125				132,138
Net change in cash, cash equivalents, and restricted cash		(189,822	)			128,982
Cash, cash equivalents, and restricted cash at beginning of year		223,720				94,738
Cash, cash equivalents, and restricted cash at end of period	$	33,898			$	223,720

 

• AFM13 combination with AB-101 NK cells: On track for IND filing in H1 2023 and initiation of clinical study in 2023
• AFM13 monotherapy REDIRECT data: Oral presentation at the AACR annual meeting
• AFM24: Data from the three ongoing studies expected to be presented at scientific conferences in Q2 or Q3 of 2023
• AFM28: Clinical phase 1 study is open and recruiting; clinical trial applications now approved in four European countries including Belgium, France, Denmark and Spain
• Anticipated cash runway into 2025: As of December 31, 2022, cash and cash equivalents were €190.3 million

HEIDELBERG, Germany, March 23, 2023 (GLOBE NEWSWIRE) — Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today reported financial results for the year ended December 31, 2022, and provided an update on clinical and corporate progress.

“During 2022, we presented data across our pipeline that show our innate cell engagers can deliver unprecedented efficacy when combined with NK cells, can activate and direct cytotoxic T cells to tumor cells, and deliver meaningful single agent activity with a differentiated safety profile,” said Adi Hoess, Chief Executive Officer at Affimed. “Supported by a cash runway into 2025, our Company is well positioned to execute on our strategic imperatives, with multiple catalysts across our pipeline expected in 2023. We are excited about this next critical stage of development which we believe can unlock the tremendous value of our platform.”

Program Updates

AFM13 (CD30/CD16A)

• In January 2023, Affimed received feedback from the Food and Drug Administration (FDA) to its pre-investigational new drug (IND) meeting request in support of a planned clinical study to investigate AFM13 in combination with Artiva’s AB-101 natural killer (NK) cells. The Company is on track to submit the IND in the first half of 2023. Pending IND clearance, Affimed expects to initiate the combination clinical trial in 2023.
• AFM13-104: In December 2022, at the American Society of Hematology annual meeting, Affimed reported updated data from AFM13-104, the investigator sponsored trial (IST) led by The University of Texas MD Anderson Cancer Center investigating the combination of AFM13 combined with cord blood-derived NK cells followed by AFM13 monotherapy.

  AFM13 in combination with NK cells showed very high overall and complete response rates in 41 heavily pre-treated CD30-positive Hodgkin lymphoma (HL) and Non-Hodgkin lymphoma (NHL) patients.

  Patients in the study had a median of seven prior lines of treatment and all patients had failed to demonstrate objective response to immediate prior line of therapy.

  In the 35 patients treated at the recommended phase 2 dose (RP2D), a 94% objective response rate (ORR) and a complete response (CR) rate of 71% were observed.

  In 31 patients with Hodgkin lymphoma treated at the RP2D, an ORR of 97% and a CR rate of 77% were observed.

  In four NHL patients treated at the RP2D, three objective responses, including one CR in a patient with peripheral T-cell lymphoma, were observed.

  63% of patients treated at the RP2D with at least 6 months of follow-up after the initial infusion (n=24) remained in complete response for at least 6 months. In addition, the treatment was well tolerated with no cases of cytokine release syndrome, immune effector cell-associated neurotoxicity or graft versus host disease observed.

  Affimed expects to present updated data from this combination study at a scientific conference later in 2023.

• AFM13-202: An abstract highlighting AFM13 data from the monotherapy study (REDIRECT) investigating efficacy in patients with CD30-positive relapsed/refractory peripheral T cell lymphomas (PTCL) has been accepted for an oral presentation at the 2023 American Association for Cancer Research (AACR) annual meeting.

AFM24 (EGFR/CD16A)

• Affimed expects to provide data updates from the three ongoing studies at scientific conferences in Q2 or Q3 of 2023. For AFM24-101, the Company expects to present data from approximately 15 patients from each of the non-small cell lung cancer and colorectal cancer cohorts. For AFM24-102 and AFM24-103, the update is expected to include data from the dose escalation portion of the respective clinical trials.
• AFM24-101: Affimed continues to enroll patients in the expansion phase of the AFM24 monotherapy study at the RP2D. The expansion cohorts include patients with renal cell carcinoma (clear cell), non-small cell lung cancer (EGFR mutant) and colorectal cancer.
• AFM24-102: In the phase 1/2a combination study of AFM24 with the anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq®) in patients with advanced epidermal growth factor receptor-expressing solid tumors, a 480 mg weekly dose of AFM24 was confirmed as the R2PD.

  The expansion cohorts for AFM24-102, which include patients with non-small cell lung cancer (EGFR wildtype), gastric and gastroesophageal junction adenocarcinoma, and a basket cohort evaluating pancreatic/hepatocellular/biliary tract cancer, are now open and enrolling patients. The treatment showed a well-managed safety profile to date.

  Data from the first cohort (4 patients at 160 mg dose) of the phase 1 dose escalation study presented at the annual meeting of the Society for Immunotherapy of Cancer (SITC) in November 2022 showed that clinical activity was observed in two patients. A patient with gastric cancer and skin metastases who had rapidly progressed following four prior lines of therapy, including a PD-1 inhibitor, achieved a partial response. A second patient with pancreatic adenocarcinoma showed stable disease beyond four months. Patients being enrolled in the study are required to have progressed or relapsed on standard of care therapies.

• AFM24-103: In the phase 1/2a combination study of AFM24 with SNK01, NKGen Biotech’s ex vivo expanded and activated autologous NK cell therapy, enrollment has been completed in the dose cohort of 480 mg AFM24 weekly, with no dose-limiting toxicities (DLTs) observed to date. The Company is recruiting three additional patients to confirm the 480 mg dose as the RP2D.

  AFM24-103 is focused on the treatment of patients with non-small cell lung cancer (NSCLC, EGFR-wildtype), squamous cell carcinoma of the head and neck, and colorectal cancer.

AFM28 (CD123/CD16A)

In December 2022, the Company announced that Clinical Trial Applications (CTAs) were cleared in France and Spain. Since then, Belgium and Denmark have also approved the Company’s CTAs. The phase 1 study is now open and recruiting patients.

AFM28 is Affimed’s tetravalent, bispecific CD123- and CD16A-binding innate cell engager (ICE®) designed to bring a new immunotherapeutic approach to patients with CD123-positive myeloid malignancies, including Acute Myeloid Leukemia and Myelodysplastic Syndrome (MDS). It engages NK cells to initiate tumor cell killing via antibody-dependent cellular cytotoxicity (ADCC), even at low CD123 expression levels.

Clinical development of AFM28 is planned as both single-agent and in combination with NK cells in patients with CD123+ myeloid disease.

Partnerships and Collaborations

Partnered programs with Genentech and Affivant Sciences (a Roivant company) continue to progress.

During 2022, Affimed continued to work with Genentech pursuant to the previously disclosed research collaboration and license agreement between the companies and handed over a number of product candidates for further investigation by Genentech.

Affivant Sciences submitted two preclinical abstracts for AFVT-2101 (formerly AFM32) which have been accepted for poster presentation at the AACR annual meeting in April 2023. Affivant expects to submit an IND for AFVT-2101 in the first half of 2023.

Full Year 2022 Financial Highlights

Affimed’s consolidated financial statements are prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standard Board (IASB). The consolidated financial statements are presented in Euros (€), the Company’s functional and presentation currency.

As of December 31, 2022, cash and cash equivalents were €190.3 million, with an anticipated cash runway into 2025.

Net cash used in operating activities for the year ended December 31, 2022 was €104.9 million compared to €86.6 million in 2021.

Total revenue for the year ended December 31, 2022, was €41.4 million compared with €40.4 million for the year ended December 31, 2021. Revenue predominately relates to the Genentech and Roivant collaborations.

Research and development expenses for 2022 increased by 21.3% from €81.5 million in 2021 to €98.8 million in 2022. The increase was primarily due to higher expenses associated with the development of the AFM24 and AFM28 programs, a result of an increase in manufacturing of clinical trial material and costs for the preparation of the filing of the IND application, an increase in costs associated with other early-stage programs and infrastructure, and an increase in share-based payment expenses.

General and administrative expenses increased 32.4% from €24.2 million in 2021, to €32.1 million in 2022. The increase predominately relates to higher personnel and share-based payment expenses and an increase in insurance premiums and higher consulting costs.

Net finance income for the year decreased from €6.5 million in 2021, to €2.1 million in 2022. Net finance income is largely due to foreign exchange gains related to assets denominated in U.S. dollars as a result of currency fluctuations between the U.S. dollar and Euro during the year.

Net loss for the year ended December 31, 2022, was €86.0 million, or €0.60 loss per common share compared with a net loss of €57.5 million, or €0.48 loss per common share, for the year ended December 31, 2021.

The weighted number of common shares outstanding for the year ended December 31, 2022 was 142.4 million.

Additional information regarding these results will be included in the notes to the consolidated financial statements as of December 31, 2022, included in Affimed’s filings with the U.S. Securities and Exchange Commission (SEC).

Note on International Financial Reporting Standards (IFRS)

Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the IASB. None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles in the United States. Affimed maintains its books and records in Euro.

Conference Call and Webcast Information

Affimed will host a conference call and webcast on March 23, 2023, at 8:30 a.m. EDT / 13:30 CET to discuss full year and Q4 2022 financial results and corporate developments.

The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the “Webcasts” section on the “Investors” page of the Affimed website at https://www.affimed.com/investors/webcasts-and-corporate-presentation/. To access the call by phone, please use link:
https://register.vevent.com/register/BIbfecf0c35a2946dc88d3ae439cb5d3e2, and you will be provided with dial-in details and a pin number.

Note: To avoid delays, we encourage participants to dial into the conference call 15 minutes ahead of the scheduled start time. A replay of the webcast will be accessible at the same link for 30 days following the call.

About Affimed N.V.

Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The Company’s proprietary ROCK® platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly-owned and partnered single agent and combination therapy programs. The ROCK® platform predictably generates customized innate cell engager (ICE®) molecules, which use patients’ immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE®. Headquartered in Heidelberg, Germany, with offices in New York, NY, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by a bold vision to stop cancer from ever derailing patients’ lives. For more about the Company’s people, pipeline and partners, please visit: www.affimed.com.

Forward-Looking Statement

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of AFM13, AFM24, AFM28 and the Company’s other product candidates, the value of its ROCK® platform, its ongoing and planned preclinical development and clinical trials, its collaborations and development of its products in combination with other therapies, the timing of and its ability to make regulatory filings and obtain and maintain regulatory approvals for its product candidates, its intellectual property position, its collaboration activities, its ability to develop commercial functions, clinical trial data, its results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which it operates, the macroeconomic trends that may affect the industry or the Company, such as the instability in the banking sector experienced in the first quarter of 2023, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation, the impact on its business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict, the fact that the current clinical data of AFM13 in combination with NK cell therapy is based on AFM13 precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to Artiva’s AB-101 and other uncertainties and factors described under the heading “Risk Factors” in Affimed’s filings with the SEC. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.

        
Investor Relations Contact
Alexander Fudukidis
Director, Investor Relations
E-Mail: [email protected]
Tel.: +1 (917) 436-8102

 

Affimed N.V.
Consolidated statements of comprehensive loss
(in € thousand)
		2022		2021		2020
Revenue		41,353		40,366		28,360
Other income – net		1,417		1,310		626
Research and development expenses		(98,814)		(81,488)		(49,989)
General and administrative expenses		(32,075)		(24,218)		(13,715)
Operating loss		(88,119 )		(64,030 )		(34,718 )
Finance income / (costs) – net		2,117		6,509		(6,647 )
Loss before tax		(86,002 )		(57,521 )		(41,365 )
Income taxes		(2)		(2)		(1)
Loss for the period		(86,004 )		(57,523 )		(41,366 )
Other comprehensive loss
Items that will not be reclassified to profit or loss
Equity investments at fair value OCI – net change in fair value		(6,047)		(7,693)		(242)
Other comprehensive loss		(6,047 )		(7,693 )		(242 )
Total comprehensive loss		(92,051 )		(65,216 )		(41,608 )
Basic and diluted loss per share in – per share (undiluted = diluted)		(0.60 )		(0.48 )		(0.50 )
Weighted number of common shares outstanding		142,362,294		119,502,384		83,471,559

Affimed N.V.
Consolidated statements of financial position
(in € thousand)
		December 31, 2022		December 31, 2021
ASSETS
Non-current assets
Intangible assets		58		1,607
Leasehold improvements and equipment		3,823		3,814
Long-term financial assets		0		12,348
Right-of-use assets		561		972
		4,442		18,741
Current assets
Cash and cash equivalents		190,286		197,630
Trade and other receivables		2,697		4,809
Inventories		628		421
Other assets and prepaid expenses		2,459		3,534
		196,070		206,394
TOTAL ASSETS		200,512		225,135
EQUITY AND LIABILITIES
Equity
Issued capital		1,493		1,234
Capital reserves		582,843		474,087
Fair value reserves		(1,231)		(5,973)
Accumulated deficit		(430,190)		(333,397)
Total equity		152,915		135,951
Non current liabilities
Borrowings		11,687		17,060
Contract liabilities		1,083		7,209
Lease liabilities		176		368
Total non-current liabilities		12,946		24,637
Current liabilities
Trade and other payables		19,077		18,860
Borrowings		5,930		580
Lease liabilities		396		683
Contract liabilities		9,248		44,424
Total current liabilities		34,651		64,547
TOTAL EQUITY AND LIABILITIES		200,512		225,135

Affimed N.V.
Consolidated statements of cash flows
(in € thousand)
		2022		2021		2020
Cash flow from operating activities
Loss for the period		(86,004)		(57,523)		(41,366)
Adjustments for the period:
– Income taxes		2		2		1
– Depreciation and amortization		2,899		1,334		1,115
– Net gain from disposal of leasehold improvements and equipment		0		0		34
– Share-based payments		19,110		11,820		3,381
– Finance income / (costs) – net		(2,117)		(6,509)		6,647
		(66,110)		(50,876)		(30,188)
Change in trade and other receivables		2,113		(2,369)		(1,065)
Change in inventories		(207)		(175)		50
Change in other assets and prepaid expenses		1,075		(2,274)		(1,260)
Change in trade, other payables, provisions and contract liabilities		(41,048)		(29,990)		12,848
		(104,177)		(85,684)		(19,615)
Interest received		564		0		294
Paid interest		(1,277)		(905)		(78)
Paid income tax		(2)		(2)		(1)
Net cash used in operating activities		(104,892 )		(86,591 )		(19,400 )
Cash flow from investing activities
Purchase of intangible assets		(37)		(1,654)		(9)
Purchase of leasehold improvements and equipment		(659)		(2,196)		(431)
Cash received from the sale of financial assets		6,301		0		0
Cash paid for investments in financial assets		0		0		(8,101)
Cash received from maturity of financial assets		0		0		16,547
Net cash generated / (used) for investing activities		5,605		(3,850 )		8,006
Cash flow from financing activities
Proceeds from issue of common shares, including exercise of share-based payment awards		95,907		124,460		74,195
Transaction costs related to issue of common shares		(6,037)		(7,412)		(2,294)
Proceeds from borrowings		0		17,500		0
Transaction costs related to borrowings		0		(311)		0
Repayment of lease liabilities		(733)		(564)		(521)
Repayment of borrowings		(580)		(92)		(2,128)
Cash flow from financing activities		88,557		133,581		69,252
Exchangerate related changes of cash and cash equivalents		3,386		7,636		(6,238 )
Net changes to cash and cash equivalents		(10,730 )		43,140		57,858
Cash and cash equivalents at the beginning of the period		197,630		146,854		95,234
Cash and cash equivalents at the end of the period		190,286		197,630		146,854

Affimed N.V.
Consolidated statements of changes in equity
(in € thousand)
		Issued capital		Capital reserves		Fair Value reserves		Accumulated deficit		Total equity
Balance as of January 1, 2020		762		270,451		1,962		(234,508 )		38,667
Issue of common shares		205		68,341						68,546
Exercise of share-based payment awards		16		2,991						3,007
Equity-settled share-based payment awards				3,381						3,381
Loss for the period								(41,366)		(41,366)
Other comprehensive loss						(242)				(242)
Balance as of December 31, 2020		983		345,164		1,720		(275,874 )		71,993
Balance as of January 1, 2021		983		345,164		1,720		(275,874 )		71,993
Issue of common shares		240		114,197						114,437
Exercise of share-based payment awards		11		2,906						2,917
Equity-settled share-based payment awards				11,820						11,820
Loss for the period								(57,523)		(57,523)
Other comprehensive loss						(7,693)				(7,693)
Balance as of December 31, 2021		1,234		474,087		(5,973 )		(333,397 )		135,951
Balance as of January 1, 2022		1,234		474,087		(5,973 )		(333,397 )		135,951
Issue of common shares		259		89,545						89,804
Exercise of share-based payment awards		0		101						101
Equity-settled share-based payment awards				19,110						19,110
Transfer of cumulative loss on sale of financial assets						10,789		(10,789)		0
Loss for the period								(86,004)		(86,004)
Other comprehensive loss						(6,047)				(6,047)
Balance as of December 31, 2022		1,493		582,843		(1,231 )		(430,190 )		152,915

Progress in Three Phase 3 Trials in Areas of High Unmet Clinical Need, Including Positive Sorbitol Reduction Data from the Ongoing Phase 3 INSPIRE Trial in Sorbitol Dehydrogenase (SORD) Deficiency

On Track to Report Additional Phase 3 Data Across Multiple Programs in 2023

NEW YORK, March 23, 2023 (GLOBE NEWSWIRE) — Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today reported financial results for the fourth quarter and full year ended December 31, 2022.

“We are pleased with the clinical progress in 2022 across all three of our registrational Phase 3 programs, and we look forward to the data readouts in the year ahead,” said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics. “Our recent deal with Advanz Pharma highlights our ability to realize value in our clinical programs, and we continue to evaluate other potential opportunities for value recognition.”

Recent Highlights

• Announced Positive Sorbitol Reduction Data from the Ongoing Phase 3 INSPIRE Trial in Sorbitol Dehydrogenase (SORD) Deficiency. In February 2023, the Company announced positive sorbitol reduction data from the ongoing global Phase 3 INSPIRE trial. The INSPIRE trial is a Phase 3 double-blind placebo-controlled registrational study evaluating the effect of once-daily oral AT-007 in approximately 50 patients age 16-55 with SORD Deficiency in the US and Europe. SORD Deficiency (also called SORD Neuropathy or CMT-SORD) is a debilitating hereditary axonal neuropathy caused by mutations in the Sorbitol Dehydrogenase gene, leading to an inability to metabolize the sugar sorbitol, and resulting in accumulation of high levels of toxic sorbitol, which causes motor neuron degeneration and loss of mobility and motility. AT-007 (govorestat) is a central nervous system penetrant Aldose Reductase Inhibitor, which blocks conversion of glucose to sorbitol, and has previously been shown to reduce sorbitol levels in an open-label pilot study in patients with SORD Deficiency. In a pre-specified interim analysis of the ongoing Phase 3 INSPIRE trial, AT-007 reduced sorbitol levels by a mean of approximately 52% (or approximately 16,000ng/ml) over 90 days of treatment (p<0.001 vs. placebo) in patients with SORD Deficiency.
• Announced Partnership with Advanz Pharma for Commercialization of Govorestat in Europe. In January 2023, the Company announced a partnership with Advanz Pharma, a pharmaceutical company with a strategic focus on commercialization of specialty, hospital, and rare disease medicines, for commercialization of govorestat in Europe. Under the terms of the agreement, the Company will receive certain near-term development milestone payments upon clinical trial completion and marketing authorization in Europe as well as commercial sales milestones, which in the aggregate amount to over €130 million, including €10 million upfront provided upon signing. The Company will receive royalties on any future net sales of govorestat in Europe of 20% and will continue to be responsible for the development, manufacturing and supply of govorestat.

Financial Results

• Cash and cash equivalents and short-term investments totaled $30.6 million as of December 31, 2022, compared with $80.8 million at December 31, 2021.  
• Research and development expenses for the year ended December 31, 2022 were $55.6 million, compared to $62.6 million for the year ended December 31, 2021. The decrease of approximately $6.9 million was primarily related to a decrease in drug manufacturing and formulation expenses of $11.0 million primarily related to the completion and release of AT-001 and AT-007 drug product batches in the year ended December 31, 2021 and a decrease of regulatory and other expenses of $0.6 million primarily related to the University of Miami license fees recognized during the year ended December 31, 2021, which was offset by an increase in clinical and pre-clinical expense of $2.6 million, primarily related to the progression of the SORD Phase 2/3 registrational study, progression of the AT-007 ACTION-Galactosemia long-term extension adult study, and progression of the AT-007 ACTION-Galactosemia Kids pediatric registrational study; an increase in personnel expenses of $1.1 million due to the increase in headcount in support of our clinical program pipeline; and an increase in stock-based compensation of $0.9 million due to new stock option and restricted stock unit grants, offset by forfeitures of stock option and restricted stock unit grants.
• General and administrative expenses were $27.3 million for the year ended December 31, 2022, compared to $43.0 million for the year ended December 31, 2021. The decrease of approximately $15.7 million was primarily related to a decrease of $9.1 million related to decreased spend for commercial operations; a decrease in personnel expenses of $1.1 million and a decrease in stock-based compensation of $2.9 million due to a decrease in headcount; a decrease of insurance expenses of $0.7 million related to decreased directors and officers liability insurance costs; and a decrease in other expenses of $2.4 million, primarily relating to decreased costs of other office expenses, which was offset by an increase in professional and legal fees of $0.5 million due to higher external legal fees.
• Net loss for the year ended December 31, 2022 was $82.5 million, or $2.18 per basic and diluted common share, compared to a net loss of $105.6 million, or $4.12 per basic and diluted common share, for the year ended December 31, 2021.

About Applied Therapeutics

Applied Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need. The Company’s lead drug candidate, AT-007 (govorestat), is a novel central nervous system penetrant Aldose Reductase Inhibitor (ARI) for the treatment of CNS rare metabolic diseases, including Galactosemia, SORD Deficiency, and PMM2-CDG. The Company is also developing AT-001, a novel potent ARI, for the treatment of Diabetic Cardiomyopathy, or DbCM, a fatal fibrosis of the heart. The preclinical pipeline also includes AT-003, an ARI designed to cross through the back of the eye when dosed orally, for the treatment of Diabetic Retinopathy.

To learn more, please visit www.appliedtherapeutics.com and follow the company on Twitter @Applied_Tx.

Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding the strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “plan,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) the anticipated benefits of the Company’s partnership with Advanz Pharma and (ii) the expected development milestone payments. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we, therefore cannot assure you that our plans, intentions, expectations or strategies will be attained or achieved.

Such risks and uncertainties include, without limitation, (i) our plans to develop, market and commercialize our product candidates, (ii) the initiation, timing, progress and results of our current and future preclinical studies and clinical trials and our research and development programs, (iii) our ability to take advantage of expedited regulatory pathways for any of our product candidates, (iv) our estimates regarding expenses, future revenue, capital requirements and needs for additional financing, (v) our ability to successfully acquire or license additional product candidates on reasonable terms and advance product candidates into, and successfully complete, clinical studies, (vi) our ability to maintain and establish collaborations or obtain additional funding, (vii) our ability to obtain and timing of regulatory approval of our current and future product candidates, (viii) the anticipated indications for our product candidates, if approved, (ix) our expectations regarding the potential market size and the rate and degree of market acceptance of such product candidates, (x) our ability to fund our working capital requirements and expectations regarding the sufficiency of our capital resources, (xi) the implementation of our business model and strategic plans for our business and product candidates, (xii) our intellectual property position and the duration of our patent rights, (xiii) developments or disputes concerning our intellectual property or other proprietary rights, (xiv) our expectations regarding government and third-party payor coverage and reimbursement, (xv) our ability to compete in the markets we serve, (xvi) the impact of government laws and regulations and liabilities thereunder, (xvii) developments relating to our competitors and our industry, (xvii) our ability to achieve the anticipated benefits from the agreements entered into in connection with our partnership with Advanz Pharma and (xiv) other factors that may impact our financial results. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur at all. Factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

Contacts

Investors:

Maeve Conneighton
(212) 600-1902 or
[email protected]

Media:

[email protected]

Applied Therapeutics, Inc.

Statements of Operations

(in thousands except share and per share data)

		Year Ended
		December 31,
		2022				2021
OPERATING EXPENSES:
Research and development		$	55,634			$	62,570
General and administrative			27,316				43,048
Total operating expenses			82,950				105,618
LOSS FROM OPERATIONS			(82,950	)			(105,618	)
OTHER INCOME (EXPENSE), NET:
Interest income			685				555
Change in fair value of warrant liabilities			(66	)			—
Other expense			(177	)			(521	)
Total other income, net			442				34
Net loss		$	(82,508	)		$	(105,584	)
Net loss attributable to common stockholders—basic and diluted		$	(82,508	)		$	(105,584	)
Net loss per share attributable to common stockholders—basic and diluted		$	(2.18	)		$	(4.12	)
Weighted-average common stock outstanding—basic and diluted			37,825,431				25,598,181

Applied Therapeutics, Inc.

Balance Sheets

(in thousands except share and per share data)

		As of				As of
		December 31,				December 31,
		2022				2021
ASSETS
CURRENT ASSETS:
Cash and cash equivalents		$	16,657			$	53,888
Investments			13,923				26,935
Prepaid expenses and other current assets			6,728				7,571
Total current assets			37,308				88,394
Operating lease right-of-use asset			857				1,298
Security deposits and leasehold improvements			198				200
TOTAL ASSETS		$	38,363			$	89,892
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Current portion of operating lease liabilities		$	477			$	442
Accounts payable			4,534				9,461
Accrued expenses and other current liabilities			14,756				16,559
Warrant liability			13,657				—
Total current liabilities			33,424				26,462
NONCURRENT LIABILITIES:
Noncurrent portion of operating lease liabilities			414				891
Clinical holdback – long-term portion			464				—
Total noncurrent liabilities			878				891
Total liabilities			34,302				27,353
STOCKHOLDERS’ EQUITY:
Common stock, $0.0001 par value; 200,000,000 shares authorized as of December 31, 2022 and 100,000,000 shares authorized as of December 31, 2021; 48,063,358 shares issued and outstanding as of December 31, 2022 and 26,215,514 shares issued and outstanding as of December 31, 2021			5				3
Preferred stock, par value $0.0001; 10,000,000 shares authorized as of December 31, 2022 and December 31, 2021; 0 shares issued and outstanding as of December 31, 2022 and December 31, 2021			–				–
Additional paid-in capital			352,828				328,958
Accumulated other comprehensive gain/(loss)			51				(107	)
Accumulated deficit			(348,823	)			(266,315	)
Total stockholders’ equity			4,061				62,539
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY		$	38,363			$	89,892